ST. JUDE MEDICAL, INC.

Manufacturer adverse-event records for ST. JUDE MEDICAL, 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 · 1993–2026 · heavy-book · elevated Death-code · injury-heavy

Volume signature

ST. JUDE MEDICAL, INC. sits in the heavy MAUDE book

ST. JUDE MEDICAL, INC. accounts for 39,263 FDA MAUDE reports (#90 of 443, heavy-book tercile). Death-coded event_type share is 1.34% (elevated); Injury share 69.4% (injury-heavy).

What the volume reading shows for ST. JUDE MEDICAL, INC.

The standout signal for ST. JUDE MEDICAL, INC. is filing volume: 39,263 adverse-event reports in FDA MAUDE (#90 of 443, heavy-book). Death-coded event_type share sits at 1.34% (elevated).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair ST. JUDE MEDICAL, 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 20 device types, led in this extract by Injury at 27,231 (69.4% of event_type total). Peak single-year volume reaches 16,992 reports across 34 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

39,263
Total Reports
526
Event-type Death
27,231
Injury Reports
20
Device Types

Event Types

Injury 27,231 (69.4%)
Malfunction 11,466 (29.2%)
Death 526 (1.3%)
28 (0.1%)
Other 12 (0.0%)

Patient Outcomes

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

Required Intervention 19,841 (43.4%)
11,244 (24.6%)
Hospitalization 6,280 (13.7%)
R 6,138 (13.4%)
Other 1,313 (2.9%)
Death 532 (1.2%)
H 175 (0.4%)
O 74 (0.2%)
Life Threatening 44 (0.1%)
L 23 (0.1%)
S 8 (0.0%)
D 5 (0.0%)
Congenital Anomaly 4 (0.0%)
Disability 1 (0.0%)

Yearly Trend

93
1993: 2
94
1994: 13
95
1995: 9
96
1996: 8
97
1997: 6
98
1998: 13
99
1999: 21
00
2000: 265
01
2001: 352
02
2002: 124
03
2003: 227
04
2004: 40
05
2005: 37
06
2006: 47
07
2007: 14
08
2008: 13
09
2009: 8
10
2010: 29
11
2011: 6
12
2012: 9
13
2013: 20
14
2014: 80
15
2015: 232
16
2016: 6,340
17
2017: 16,992
18
2018: 5,801
19
2019: 1,734
20
2020: 1,028
21
2021: 954
22
2022: 954
23
2023: 1,985
24
2024: 1,766
25
2025: 133
26
2026: 1