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Leads Performance Analysis
Implanted leads operate in the challenging biochemical environment of the human body and the body's response to foreign objects. Implanted leads are also subject to mechanical stresses associated with heart motion, body motion, and patient anatomy.
In this environment, pacemaker and defibrillation leads cannot be expected to last forever. While IPGs and ICDs have a battery that will deplete after a predictable length of time, a lead's longevity cannot be predicted, nor are there simple indicators that a lead is approaching the end of its service life. Therefore, regular monitoring while implanted, and evaluation of lead integrity upon IPG or ICD replacement, is necessary to determine if a lead may be approaching the end of its service life.
Shortfalls Of Using Returned Product And Complaints To Estimate Lead Performance
Leads and lead segments returned to Medtronic are analyzed to determine whether or not they meet performance limits established by Medtronic. Although returned product analyses are valuable for gaining insight into lead failure mechanisms, this data cannot be used by itself for determining the survival probability of leads because only a small fraction of leads are explanted and returned for analysis. Additionally, those leads that are returned cannot be assumed to be statistically representative of the performance of the total population for a given lead model. Partial or total lead extraction can result in significant damage to a lead, making a definitive analysis of a suspected failure, and its cause, impossible.
To account for the under reporting inherent with lead survival analysis based solely on returned product, some manufacturers add reported complaints where adverse product performance is evident but the product itself has not been returned. The improvement to the accuracy of survival estimates depends on the degree to which all complaints are actually communicated to the manufacturer. Since not all complaints are communicated to the manufacturer, adding complaints to the survival analysis does not completely solve the under reporting problem.
Thus, lead survival probabilities are more appropriately determined through a clinical surveillance study that includes active follow up with the patients. Although Medtronic monitors returned product analysis and complaints, these are not used to determine lead survival estimates.
Medtronic tracks lead survival through its Product Surveillance Registry. The registry is designed to record clinical observations representative of the total clinical experience. Therefore, the lead survival estimates include both lead hardware failure and lead-related medical complications, and do not differentiate a lead hardware failure from other clinical events such as exit block, perforation, dislodgement, or concurrent pulse generator failure. The lead need not be returned to Medtronic.
Product Surveillance Registry
Medtronic has been monitoring the performance of its cardiac therapy products with a multicenter study since 1983 and has evaluated the performance of more than 95,000 leads, with data reported from countries around the world. Throughout this time period, Medtronic has continually worked to adapt systems and processes to more effectively monitor product performance following market release. The following summarizes current registry requirements.
Medtronic's global product surveillance registry has a prospective, non-randomized, observational design. A key purpose of the registry is to provide continuing evaluation and periodic reporting of the long-term reliability and performance of Medtronic market-released cardiac therapy products. Product-related adverse events, indicating the status of the product, are collected to measure survival probabilities. The data gathered may also be used to support the design and development of investigational plans for new cardiac therapy products. The registry is designed to continue indefinitely, encompassing new products as they become commercially available.
To ensure a sufficiently large and representative source of data, participating clinical sites must meet pre-specified selection criteria. The number of participants is regularly reviewed to ensure the necessary capacity to meet Medtronic's ongoing prospective post-market surveillance needs is available. Every effort is made to ensure participants are representative of the range of clinical environments in which Medtronic cardiac rhythm products are used. Eligible products for enrollment include Medtronic market-released cardiac rhythm therapy products for which additional information to further characterize product performance following market release is desired. Enrollment may be capped at a product when the number enrolled ensures sufficient precision to effectively characterize product survivability.
Enrolled patients are followed in accordance with the standard care practices of their care provider from their implant date until they can no longer be followed (e.g., death, lost to follow-up, etc.). However, to ensure regular patient status assessments are completed, follow-up windows consistent with typical care practices have been established with a minimum annual follow-up requirement. Product-related adverse events, system modifications and changes in patient status (e.g. death and withdrawal from the study) are required to be reported upon occurrence. This active surveillance model ensures a robust dataset for effectively monitoring product performance.
Patients are eligible for enrollment if:
- They are intended to be implanted or are within 30 days post-implant of a Medtronic market-released lead connected to a market-released CRT, ICD, or IPG device, and the lead is used for a pacing, sensing, or defibrillation application, or
- They participated in a qualifying investigational study of a Medtronic cardiac therapy product that is now market-released; complete implant and follow-up data are available; and the data can be appropriately and legally released.
Each site must inform Medtronic whenever a lead complication has occurred or when a patient is no longer participating. Chronic product performance is analyzed as a function of time using the survival analysis method.
Medtronic continually evaluates the quality and integrity of the data through a combination of on-site and centralized monitoring activities.
Lead Complications
The data presented characterizes chronic lead performance by estimating lead related complication free survival probabilities. For analysis purposes, the complication criteria, which align with the AdvaMed 'Industry Guidance for Uniform Reporting of Clinical Performance of Cardiac Rhythm Management Pulse Generators and Leads', are defined below. These criteria do not, however, enable a lead integrity or "hardware" failure to be conclusively differentiated from other clinical events such as an undetected lead dislodgement, exit block, or concurrent pulse generator failure manifested as a sensing or capture problem.
All reported lead-related adverse events are classified by the reporting investigator and are adjudicated by an independent event adjudication committee[1](During the evolution of PSR, event adjudication was transitioned from a Medtronic technical review committee to an independent event adjudication committee in 2011. Data analyses include adjudication using both methods). A lead-related complication is considered to have occurred if a clinical observation occurs more than 30 days after implant, is adjudicated with at least one of the following event classifications and at least one of the following clinical actions is made. Events with an onset date 30 days or less after the implantare considered procedure related and therefore not included as chronic lead-related complications.
Event Classifications
- Failure to capture
- Failure to sense/undersensing
- Oversensing
- Abnormal pacing impedance (based on lead model, but normal range is typically 200 - 2,000 ohms)
- Abnormal defibrillation impedance (based on lead model, but normal range is typically 20 - 200 ohms)
- Insulation breach
- Conductor fracture, confirmed electrically, visually or radiographically
- Extracardiac stimulation
- Cardiac perforation
- Lead dislodgement
Clinical Actions
- Lead surgically abandoned/capped
- Lead electrically abandoned
- Lead explanted
- Lead replaced
- Lead conductor taken out of service (polarity reprogrammed to remove defective conductor, e.g. bipolar to unipolar)
- Lead use continued based on medical judgment despite a known clinical performance issue
- Other lead-related surgery performed (e.g., lead mechanical alteration or unsuccessful repositioning)
Data Analysis Methods
The performance of leads is expressed in terms of lead survival estimates, where "survival" refers to the function of the lead, not the survival of the patient. These survival estimates are intended to illustrate the probability that a lead will survive for a given number of years without a chronic lead-related complication.
Survival times are calculated from the implant date to the earliest of the complication date, out-of-service date (for example, subject leaves the study or the lead is no longer being used) or the last follow-up date. If a lead experiences more than one complication, the first is used to calculate survival time; although all complications associated with a lead are included in the summary tables.
Of the several different statistical methods available for survival analysis, the Standard Actuarial Method, with suspensions assumed distributed across the intervals (Cutler-Ederer Method), is used to determine estimates of lead survival.
On the following pages, each graph includes a survival curve where events include qualifying lead-related complications. This survival estimate is a good representation of the probability a lead will survive a period of time without a lead-related complication. For example, if a survival probability is 95% after 5 years of service, then the lead has a 5% chance of experiencing a lead-related complication in the first 5 years following implant.
Although tabular data is provided in 1-year intervals, the curves are actually computed and plotted using 3-month intervals.
The data in the tables is rounded to the nearest tenth of one percent. Occasionally, a graph may show 100% survival, but have one or more complications. This occurs because even with the complications, the data rounds to 100%.
The survival curves are statistical estimates. As performance experience accumulates, the estimation improves. Confidence intervals are provided as a way to indicate the degree of certainty of the estimates. Greenwood's formula is used to calculate the standard errors, and the log-log method is used to produce the 2-sided 95% confidence bounds.
Since the survival estimate can become very imprecise with small effective sample sizes, Medtronic truncates the survival curve when the number of leads entering an interval is less than 50 leads. When the number of leads entering an interval reaches 50, the next data point is added to the survival curve. For those lead models that do not have sufficient sample size, a survival curve will not be presented.
Definition of Analysis Dataset
The survival estimates are derived from all device components successfully enrolled as of the data cutoff date. The number of enrollments is listed for each lead model.
This sample is considered to be representative of the worldwide population, and therefore the survival estimates shown should be representative of the performance worldwide of these models.
Criteria for Model Inclusion
Performance information for a model or model family will be published when more than 100 leads have been enrolled and no fewer than 50 leads followed for at least 6 months. Models will continue to be published for at least 20 years as long as Medtronic estimates at least 500 leads remain active in the United States, based on estimated US implants.
Medtronic, at its discretion, may stop providing updated performance information on lead models that received original US market-release approval 20 or more years ago.
Returned Product Analysis Results
Although the returned product analysis data is not used to generate the survival estimates, the data provides valuable insight into the causes of lead malfunction.
For reporting returned product analysis results, Medtronic CRDM considers a lead as having malfunctioned whenever the analysis shows that any parameter was outside the performance limits established by Medtronic while implanted and in service. To be considered a malfunction for returned product analysis reporting, the lead must have been returned to Medtronic and analyzed.
The results of the analysis is presented in four categories. The lead reporting categories are:
Conductor Fracture: Conductor malfunction with complete or intermittent loss of continuity that could interrupt current flow (e.g., fractured conductors), including those associated with clavicle flex fatigue or crush damage.
Insulation Breach: A malfunction of the insulation allowing inappropriate entry of body fluids or inappropriate current flow between the conductors, or between the conductor and the body. Examples include cuts, tears, depressions, abrasions, and material degradation.
Crimps/Welds/Bonds: Any malfunction in a conductor or lead body associated with a point of connection.
Other: Malfunctions of specific lead mechanical attributes, such as sensors, connectors, seal rings, or malfunction modes not included in the three categories above.
A lead subject to a safety advisory is not considered to have malfunctioned unless it has been returned to Medtronic CRDM and found, through analysis, to actually have performed outside the performance limits established by Medtronic.
For leads designed for either ventricular or atrial use, the numbers listed in the Returned Product Analysis tables include both.
The numbers of malfunctions listed in the Returned Product Analysis tables are the actual numbers confirmed in the returned product analysis. The numbers of complications listed in the complications tables are the actual numbers observed in the PSR centers around the world.
US Reports of Acute Lead Observations (Occurring within First Month of Service)
In the first weeks following lead implantation, physiologic responses and lead performance can vary until long-term lead stability is attained. Acute (defined as the first month after implant) lead performance may be subject to a number of factors, including patient-specific anatomy, clinical conditions and/or varying implant conditions/techniques. After a period of time, the implant and the lead performance stabilizes. It is for this reason that the Product Surveillance Registry results, which are intended to measure long-term performance, do not include complications that occur within the first 30 days after implant.
Information about the clinical experience in the first month of service is included in our reporting. The source for this information is Medtronic's complaint handling system database. The information is summarized in tables titled "US Reports of Acute Lead Observations."
Each Event Report received by Medtronic's complaint handling system is assigned one or more Reason for Report codes based on the information received. The Reason for Report codes have been grouped into Acute Lead Observation categories. The categories used for this product performance reporting are drawn from the "FDA Guidance for Submission of Research and Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead Adapter 510(k) Submissions." The categories are:
- Cardiac Perforation
- Conductor Fracture
- Lead Dislodgement
- Failure to Capture
- Oversensing
- Failure to Sense
- Insulation Breach
- Impedance Abnormal
- Extracardiac Stimulation
- Unspecified
Although multiple observations are possible for any given lead, only one observation is reported per lead. The observation reported is the observation highest on the list. For example, if an Event Report includes observations for both Lead Dislodgement and Failure to Sense, Lead Dislodgement is reported.
The lead event reported to Medtronic may or may not have involved clinical action or product returned to Medtronic. The lead may have remained implanted and in service.
Estimated Number of Implanted and Active Leads in the United States
In addition to providing the number of leads enrolled in the PSR, we also provide the number of leads registered as implanted and the number remaining active in the United States based on the status recorded in the Medtronic Device and Registrant Tracking system.
Methods for Estimating
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Worldwide Contact Information


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The V&E Department combines the sciences of viticulture and enology in a single research and teaching unit that encompasses all of the scientific disciplines that impact grape growing and winemaking. For over one hundred years the University of California has maintained an active and productive program in research and education in viticulture and enology. The continuing excellence of the Department has enabled California growers and vintners to develop practices that have allowed the Golden State to achieve its potential and become a premier wine-producing region.
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Muhammad Zulfahmi Khaiuddin was born in Selangor, Malaysia on October 20, 1991. He has been racing in the MotoGP class since 2009, most recently for the Airasia Sic Ajo Team and stays with this team, which in 2012 races the KTM Moto3 bike. Zulfahmi made his race debut at the 2009 GP of Malaysia as a wild card entry. His first full season was 2010 where he had a top 15 finish at the GP of the Czech Republic at the Brno racing circuit. He raced a whole season in 2011, picking up 30 world championship points to finish overall eighteenth in the championship. He rides the KTM Moto3 bike # 63.
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Hobbies | |
Favorite track | |
Goals | |
Bike | KTM 250 FFR |
Mechanic | |
Class | Moto3 |


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Shelby County Halloween Attractions & Events
Shelby has some of the best Haunted Attractions in AL, so whether you're looking for a good fright, want to go pumpkin picking, or you're simply looking to create amazing Fall Memories, then you'll want to head out to Shelby this Halloween Season. From terrifying chills, to exhilarating thrills Shelby has something to offer for everyone - from families in search of kid-friendly Fall fun, to friends looking to spend an evening at some of the spookiest Haunts in AL. Halloween is almost upon us, make sure to check out what Shelby has to offer this Autumn - you won't be disappointed!
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Vanessa Williams
Vanessa Williams
Original Release Date: August 26, 1997
Track Listing
1. Who Were You Thinkin' 'Bout?
2. Happiness
3. And My Heart Goes
4. First Thing On Your Mind
5. Crazy 'Bout You
6. Lost Without You
7. Someone Like You
8. The Easiest Thing
9. Surrender
10. Start Again
11. And If I Ever
12. Oh How the Years Go By
Mark Egan: Bass
Ada Dyer: Vocals, Vocals (Background), Choir, Chorus
Vanessa Williams: Vocals (Background), Executive Producer
Dave Koz: Saxophone
Jeremy Lubbock: Conductor, String Arrangements
Sharon Bryant: Vocals (Background)
Audrey Wheeler: Vocals (Background), Choir, Chorus
Phil Madeira: Organ (Hammond), Lap Steel Guitar
Sue Ann Carwell: Vocals (Background), Vocal Arrangement
Trey Lorenz: Vocals (Background)
Angela Clemmons-Patrick: Vocals (Background)
Ronn Huff: Conductor, String Arrangements
R. Kelly: Vocals (Background), Producer, Mixing
Jill Dell'Abate: Production Coordination
Scott Ahaus: Assistant Engineer
Joe Alexander: Engineer
Paul Arnold: Engineer
Jerry Barnes: Vocals (Background)
Katreese Barnes: Vocals (Background)
Bashiri Johnson: Percussion
Bob Brockman: Mixing
Nick Brophy: Assistant Engineer
Bruce Carbone: Executive Producer
Lafayette Carthon: Keyboards
David Cerutti: Viola
Jules Chaiken: Conductor, String Contractor
Steve Crawford: Vocals, Choir, Chorus
Barry J. Eastmond: Arranger, Keyboards, Producer
Rob Eaton: Engineer, Mixing
Phil Galdston: Composer
Trevor Gale: Drum Programming
Jon Gass: Mixing
Humberto Gatica: Engineer
Mick Guzauski: Engineer, Mixing
Mark Hammond: Drum Programming
Chris Harris: Conductor, Vocals
Steve Hodge: Engineer, Mixing
Dann Huff: Guitar
Jimmy Jam: Arranger, Producer
Chuck Kawal: Guitar (Acoustic), Guitar (Electric)
Adam Kudzin: Engineer
Sonny Lallerstedt: Guitar (Acoustic)
Will Lee: Bass
Terry Lewis: Arranger, Producer
Mark Shulman: Guitar (Electric)
Rob Mathes: Strings, Arranger, Keyboards, Organ (Hammond), Vocals (Background), Guitar (12 String), Producer
Shawn McLean: Assistant Engineer
Jerry McPherson: Guitar
Michael Mellett: Vocals, Choir, Chorus
Joey Miskulin: Accordion
Cindy Mizelle: Vocals (Background), Choir, Chorus
The Nashville String Machine: Strings
Shawn Pelton: Drums
George Pendergrass: Choir, Chorus
Gary Pigg: Vocals, Choir, Chorus
Herb Powers: Mastering
Darin Prindle: Engineer
Eric Rehl: Synthesizer, Programming, Synthesizer Programming
Dave Reitzas: Engineer
Cindy Richardson: Vocals, Choir, Chorus
Daryl Simmons: Synthesizer, Arranger, Programming, Synthesizer Programming
Jimmie Lee Sloas: Bass
Richard Travali: Mixing
Stan Wallace: Engineer
Denise Walls: Choir, Chorus
Bill Whittington: Engineer, Mixing
Peter Wyrick: Cello, Celli
Tom Bender: Mixing Assistant
Richard Brice: Viola
Greg Parker: Assistant Engineer
Stephen George: Programming, Engineer, Mixing
Lisa Cochran: Vocals (Background), Choir, Chorus
Rick Dolan: Violin
Tabitha Fair: Vocals, Choir, Chorus
Cynthia Jernigan: Vocals (Background)
Dan Needham: Drums
Joel Pitchon: Violin
Eric Wyrick: Concert Master
Billy Gaines: Vocals
Marnie Riley: Assistant Engineer, Mixing Assistant
Margery Greenspan: Art Direction
Ron Lowe: Assistant Engineer, Mixing Assistant
Jeff Kievit: Producer
John R. Reigart III: Mixing Assistant
Casey Stone: Assistant Engineer
Chris Brickley: Programming, Engineer
Jason Bacher: Assistant Engineer
Joe Lizzi: Assistant Engineer
Peter Winograd: Violin, Viola
Kevyn Aucoin: Photography
Pete Karam: Assistant Engineer
Roger Shell: Cello
Trey Fratt: Assistant Engineer
Kenny LaMar: Arranger
Antonina Armato: Arranger, Producer
Adrian Johnson Ross: Vocals (Background)
Dennis Ross III: Piano, Keyboards, Vocals (Background), Producer
Ray Lubrana: Engineer
Robert "P-Nut" Johnson: Choir, Chorus
Clayton Sears: Bass
LaJuan Carter: Vocals (Background)
John Dukakis: Executive Producer
Qadree el-Amin: Executive Producer
Jan Folkson: Programming
Wade Thoren: Assistant Engineer
Pete Karem: Assistant Engineer
Michael Black: Vocals, Choir, Chorus
Tim Davis: Choir, Chorus
James Harris III: Composer
Shaun Shankel: Production Coordination
Adrianne Johnson Ross: Composer
Simon Crispin Climie: Composer


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Highland Career Network
Great people build great companies. As lead and active investors, we're always looking for exceptional people to join one of our portfolio companies.
We designed Highland Career Network to match professionals seeking their next outstanding career opportunity. As a centralized listing of career opportunities across Highland-backed companies, our Career Network enables you to search job listings according to a number of criteria, view detailed job descriptions, refer talented friends & colleagues to openings and submit background information directly to one of our hiring companies.
For those that would like to receive periodic or immediate updates on new positions, subscribe to our complimentary Highland Career Network Newsletter and follow us on Twitter. Also, feel free to tell a friend about the career opportunities listed on the Highland Career Network.
Title | Company | Location |
Analyst | Gemvara | Boston, Massachusetts |
Senior Manager, Jewelry Quality Control | Gemvara | New York City, New York |
Director, Human Resources | Gemvara | Boston, Massachusetts |


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Master Calendar
Excellence in Teaching Symposium
From site: News & Events
Date: Monday, February 18th, 2013
Time: 7:00 pm
Duration: 2 hours
Location: Richardson Auditorium, Morse-Ingersoll Hall
Sponsored by: Education and Youth Studies
Contact: firstname.lastname@example.com, Contact: Education and Youth Studies 363-2325
"Roma Children in Special Schools in Europe," a public lecture presented by Dr. Hristo Kyuchukov, lecturer at the Free University of Berlin. Dr. Kyuchukov has published widely on the language development and schooling of Romani children, as well as publishing two award winning children's books in English. His current research focuses on second language literacy in multilingual settings.
This event is free and open to the campus and community.


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