ST. JUDE MEDICAL

Manufacturer adverse-event records for ST. JUDE MEDICAL 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 · 1992–2026 · heavy-book · elevated Death-code · balanced

Death-code intensity

ST. JUDE MEDICAL carries an elevated Death-code share

Death-coded event_type rows are 490 of 20,624 (2.38% · elevated tercile among 443 manufacturers). Absolute volume is heavy-book.

What the Death-code reading shows for ST. JUDE MEDICAL

The standout signal for ST. JUDE MEDICAL is Death-code intensity: 2.38% of 20,624 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 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 20 device types, led in this extract by Malfunction at 11,686 (56.7% of event_type total). Peak single-year volume reaches 8,167 reports across 34 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

20,624
Total Reports
490
Event-type Death
8,255
Injury Reports
20
Device Types

Event Types

Malfunction 11,686 (56.7%)
Injury 8,255 (40.0%)
Death 490 (2.4%)
Other 146 (0.7%)
47 (0.2%)

Patient Outcomes

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

13,205 (58.7%)
Required Intervention 3,689 (16.4%)
Other 1,703 (7.6%)
R 1,446 (6.4%)
Hospitalization 1,274 (5.7%)
Death 461 (2.0%)
Life Threatening 258 (1.1%)
L 182 (0.8%)
O 129 (0.6%)
H 77 (0.3%)
S 33 (0.1%)
Disability 22 (0.1%)
D 17 (0.1%)
Congenital Anomaly 2 (0.0%)
Invalid Data 2 (0.0%)

Yearly Trend

92
1992: 4
93
1993: 4
94
1994: 5
95
1995: 25
96
1996: 2
97
1997: 4
98
1998: 4
00
2000: 18
01
2001: 3
02
2002: 12
03
2003: 16
04
2004: 68
05
2005: 225
06
2006: 315
07
2007: 375
08
2008: 417
09
2009: 378
10
2010: 343
11
2011: 302
12
2012: 262
13
2013: 235
14
2014: 192
15
2015: 236
16
2016: 298
17
2017: 502
18
2018: 698
19
2019: 1,264
20
2020: 1,059
21
2021: 1,639
22
2022: 1,314
23
2023: 8,167
24
2024: 1,518
25
2025: 700
26
2026: 20