CARDIAC PACEMAKERS, INC

Manufacturer adverse-event records for CARDIAC PACEMAKERS, INC 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 · 1999–2023 · heavy-book · elevated Death-code · balanced

Death-code intensity

CARDIAC PACEMAKERS, INC carries an elevated Death-code share

Death-coded event_type rows are 542 of 34,156 (1.59% · elevated tercile among 443 manufacturers). Absolute volume is heavy-book.

What the Death-code reading shows for CARDIAC PACEMAKERS, INC

The standout signal for CARDIAC PACEMAKERS, INC is Death-code intensity: 1.59% of 34,156 reports (elevated tercile), while absolute volume is heavy-book.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair CARDIAC PACEMAKERS, INC with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 14 device types, led in this extract by Malfunction at 20,128 (58.9% of event_type total). Peak single-year volume reaches 11,733 reports across 8 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

34,156
Total Reports
542
Event-type Death
13,486
Injury Reports
14
Device Types

Event Types

Malfunction 20,128 (58.9%)
Injury 13,486 (39.5%)
Death 542 (1.6%)

Patient Outcomes

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

Other 20,105 (58.8%)
Required Intervention 13,448 (39.4%)
Death 540 (1.6%)
55 (0.2%)
R 14 (0.0%)
Hospitalization 6 (0.0%)
L 2 (0.0%)
Life Threatening 2 (0.0%)
O 1 (0.0%)

Yearly Trend

99
1999: 1
03
2003: 1,043
04
2004: 2,359
05
2005: 2,438
06
2006: 6,748
07
2007: 9,833
08
2008: 11,733
23
2023: 1