ST. JUDE MEDICAL, INC., CRMD

Manufacturer adverse-event records for ST. JUDE MEDICAL, INC., CRMD 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 · 1998–2015 · heavy-book · elevated Death-code · balanced

Death-code intensity

ST. JUDE MEDICAL, INC., CRMD carries an elevated Death-code share

Death-coded event_type rows are 2,018 of 47,530 (4.25% · elevated tercile among 443 manufacturers). Absolute volume is heavy-book.

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

The standout signal for ST. JUDE MEDICAL, INC., CRMD is Death-code intensity: 4.25% of 47,530 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, INC., CRMD 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 18 device types, led in this extract by Malfunction at 23,259 (48.9% of event_type total). Peak single-year volume reaches 28,499 reports across 12 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

47,530
Total Reports
2,018
Event-type Death
22,220
Injury Reports
18
Device Types

Event Types

Malfunction 23,259 (48.9%)
Injury 22,220 (46.7%)
Death 2,018 (4.2%)
22 (0.0%)
Other 11 (0.0%)

Patient Outcomes

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

24,109 (50.4%)
Required Intervention 18,479 (38.7%)
Other 2,680 (5.6%)
Death 2,019 (4.2%)
Hospitalization 233 (0.5%)
R 213 (0.4%)
L 18 (0.0%)
O 11 (0.0%)
Life Threatening 11 (0.0%)
H 6 (0.0%)
S 4 (0.0%)
Congenital Anomaly 3 (0.0%)
Disability 2 (0.0%)
D 1 (0.0%)

Yearly Trend

98
1998: 55
99
1999: 106
00
2000: 267
01
2001: 421
02
2002: 467
03
2003: 543
04
2004: 494
05
2005: 220
06
2006: 561
13
2013: 5,547
14
2014: 28,499
15
2015: 10,350