CARDIAC PACEMAKERS

Manufacturer adverse-event records for CARDIAC PACEMAKERS come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 1993–2008 · mid-book · elevated Death-code · balanced

Death-code intensity

CARDIAC PACEMAKERS carries an elevated Death-code share

Death-coded event_type rows are 117 of 9,857 (1.19% · elevated tercile among 434 manufacturers). Absolute volume is mid-book.

What the Death-code reading shows for CARDIAC PACEMAKERS

The standout signal for CARDIAC PACEMAKERS is Death-code intensity: 1.19% of 9,857 reports (elevated tercile), while absolute volume is mid-book.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for CARDIAC PACEMAKERS. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 12 device types, led in this extract by Malfunction at 6,507 (66.0% of event_type total). Peak single-year volume reaches 2,963 reports across 15 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

9,857
Total Reports
117
Event-type Death
3,232
Injury Reports
12
Device Types

Event Types

Malfunction 6,507 (66.0%)
Injury 3,232 (32.8%)
Death 117 (1.2%)
Other 1 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Other 6,520 (66.1%)
Required Intervention 3,212 (32.5%)
Death 117 (1.2%)
R 10 (0.1%)
Invalid Data 5 (0.1%)
Hospitalization 2 (0.0%)
1 (0.0%)
H 1 (0.0%)

Yearly Trend

93
1993: 1
94
1994: 1
96
1996: 7
97
1997: 2,963
98
1998: 1,589
99
1999: 825
00
2000: 1,252
01
2001: 1,102
02
2002: 1,083
03
2003: 370
04
2004: 111
05
2005: 69
06
2006: 121
07
2007: 169
08
2008: 194