ST. JUDE MEDICAL, INC.(CRM-SYLMAR)

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 · 2012–2026 · heavy-book · elevated Death-code · balanced

Volume signature

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

ST. JUDE MEDICAL, INC.(CRM-SYLMAR) accounts for 192,101 FDA MAUDE reports (#16 of 443, heavy-book tercile). Death-coded event_type share is 2.70% (elevated); Injury share 49.0% (balanced).

What the volume reading shows for ST. JUDE MEDICAL, INC.(CRM-SYLMAR)

The standout signal for ST. JUDE MEDICAL, INC.(CRM-SYLMAR) is filing volume: 192,101 adverse-event reports in FDA MAUDE (#16 of 443, heavy-book). Death-coded event_type share sits at 2.70% (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 94,120 (49.0% of event_type total). Peak single-year volume reaches 24,921 reports across 13 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

192,101
Total Reports
5,188
Event-type Death
94,120
Injury Reports
20
Device Types

Event Types

Injury 94,120 (49.0%)
Malfunction 92,790 (48.3%)
Death 5,188 (2.7%)
3 (0.0%)

Patient Outcomes

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

93,177 (47.3%)
Required Intervention 86,308 (43.9%)
Death 5,029 (2.6%)
Other 4,807 (2.4%)
R 3,541 (1.8%)
Hospitalization 1,850 (0.9%)
O 851 (0.4%)
Life Threatening 559 (0.3%)
L 353 (0.2%)
H 187 (0.1%)
D 86 (0.0%)
Congenital Anomaly 53 (0.0%)
Disability 5 (0.0%)
S 4 (0.0%)
C 2 (0.0%)

Yearly Trend

12
2012: 1
15
2015: 5,631
16
2016: 7,461
17
2017: 11,280
18
2018: 16,745
19
2019: 14,792
20
2020: 16,372
21
2021: 23,220
22
2022: 24,921
23
2023: 24,019
24
2024: 22,025
25
2025: 22,334
26
2026: 3,300