December 1, 2002Pacing and Clinical Electrophysiology
Changing Trends in Pacemaker and Implantable Cardioverter Defibrillator Generator Advisories
Key result
Pacemaker and ICD advisories in the late 1990s affected a three-fold higher number of devices per advisory compared to the early 1990s (364,084 vs 159,061 total devices).
Population
Pacemaker and implantable cardioverter defibrillator generator advisories from weekly FDA Enforcement…
Design
Other
Authors
Discussion
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Implication
Increased advisory scale with device complexity warrants clinician vigilance; leaves open whether modern surveillance needs regulatory evolution.
Study Design
Type
Observational (n=523,145)
Structured PICO
P
Population
Pacemaker and implantable cardioverter defibrillator (ICD) generator advisories from weekly FDA Enforcement Reports from January 1991 to December 2000 (total 52 advisories affecting 523,145 devices)
C
Comparator
Early 1990s (1991-1995) compared to late 1990s (1996-2000)
O
Outcome
Changing patterns of device advisory type, frequency, and number of devices affectedsafety
Technological advances in pacemakers and ICDs have been accompanied by a shift in advisory types, with significant increases in electrical and battery malfunctions affecting larger numbers of devices.
Cite This Study
Maisel et al. (2002) conducted an observational in Pacemaker and ICD generator advisories (n=523,145). Late 1990s (1996-2000) timeframe vs. Early 1990s (1991-1995) timeframe was evaluated on Number and type of device advisories and affected devices. Pacemaker and ICD advisories in the late 1990s affected a three-fold higher number of devices per advisory compared to the early 1990s (364,084 vs 159,061 total devices).