ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION

Manufacturer adverse-event records for ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT D… 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 · 1998–2023 · heavy-book · elevated Death-code · injury-heavy

Death-code intensity

ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT D… carries an elevated Death-code share

Death-coded event_type rows are 1,431 of 55,211 (2.59% · elevated tercile among 443 manufacturers). Absolute volume is heavy-book.

What the Death-code reading shows for ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION

The standout signal for ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION is Death-code intensity: 2.59% of 55,211 reports (elevated tercile), while absolute volume is heavy-book.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT D… 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 15 device types, led in this extract by Injury at 35,745 (64.7% of event_type total). Peak single-year volume reaches 12,976 reports across 17 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

55,211
Total Reports
1,431
Event-type Death
35,745
Injury Reports
15
Device Types

Event Types

Injury 35,745 (64.7%)
Malfunction 17,980 (32.6%)
Death 1,431 (2.6%)
55 (0.1%)

Patient Outcomes

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

Required Intervention 35,649 (64.4%)
17,960 (32.4%)
Death 1,438 (2.6%)
R 130 (0.2%)
Hospitalization 92 (0.2%)
Other 64 (0.1%)
Life Threatening 8 (0.0%)
L 6 (0.0%)
H 5 (0.0%)
S 1 (0.0%)

Yearly Trend

98
1998: 477
99
1999: 767
00
2000: 1,405
01
2001: 902
02
2002: 723
03
2003: 564
04
2004: 487
05
2005: 351
06
2006: 1,770
07
2007: 2,973
08
2008: 3,668
09
2009: 3,939
10
2010: 5,423
11
2011: 7,985
12
2012: 10,800
13
2013: 12,976
23
2023: 1