Presentation: Pacemaker and ICD Generator Malfunctions - William H.
Maisel, MD, MPH
Beth Israel Deaconess Medical Center
Harvard Medical School
Special Government Employee
Food and Drug Administration
Center for Devices and Radiologic Health
Rockville, MD |
(Read Only)
|
Other FDA/CDRH Contributors Include:
Megan Moynahan, MS Branch Chief, Pacing, Defibrillation and Leads Branch
Bram Zuckerman, MD Director, Division of Cardiovascular Devices
Tom Gross, MD, MPH Director, Post-Market Surveillance, OSB
Oscar Tovar-Calderon, MD Medical Officer
Donna-Bea Tillman, Ph.D, MPA Director, Office of Device Evaluation
Dan Schultz, MD Director, CDRH
Methodology
Comprehensive Review of PM/ICD Manufacturer Annual Reports, 1990-2002
- Annual # Device Implants
- Annual # Units Returned for Cause
Device Malfunction Was Defined As:
(ALL 3 CRITERIA MUST BE MET)
- A Device Malfunction Resulting in Device Explant
- Device Returned to Manufacturer
- Manufacturer Confirmed Malfunction
DOES NOT INCLUDE Normal Battery Depletion, Explants Working Normally, Normally
Functioning Devices Explanted for Advisory, Leads or Lead-Related Issues
Annual Pacemaker and ICD Implants in the United States
Annual Pacemaker and ICD Malfunctions in the United States
Type and Frequency of Malfunctions
17323 PM and ICD Malfunctions
Pacemaker and ICD Generator Replacement Rates for Malfunction
Reported DEATHS due to PM or ICD Malfunction 1990-2002
- Only DEATHS CONFIRMED to be due to device malfunction were included
- Witnessed
- Device Explanted
- Manufacturer Confirmed Malfunction
~2.67 Million Implants
61 Deaths (30 PM – 31 ICD
Limitations
- Potential Underreporting of Malfunctions
- Subject to Changes in Reporting Frequency
- Assumptions
- Unreported Time From Implant to Failure
- Counts All Malfunctions as the “Same”
How do these findings compare to other non-FDA databases??
- Meta-Analysis of Public Device Registries
- Search of MEDLINE, Cochrane Databases
- Only Registries That Allowed Determination of BOTH Numerator and Denominator
Included
- United Kingdom PM and ICD Registry
- Danish PM and ICD Registry
- Bilitch Registry
Pacemaker Generator Malfunction Rates
Meta-Analysis of Non-FDA Published Registries
ICD Generator Malfunction Rates
Meta-Analysis of Non-FDA Published Registries
ICD Generator Malfunction Rates
Conclusions
- The number of PM and ICD annual implants increased substantially from 1990
to 2002.
- Thousands of patients have been affected by PM and ICD malfunctions.
- The malfunction replacement rate for ICDs is considerably higher than that
of PMs.
- The ICD malfunction replacement rate appears to be increasing.
- PMs and ICDs have saved countless lives and remain an important therapy
for patients with or at risk for life threatening arrhythmias.
Updated September 16, 2005
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