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

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 · 2013–2024 · heavy-book · elevated Death-code · injury-heavy

Death-code intensity

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

Death-coded event_type rows are 4,124 of 53,055 (7.77% · elevated tercile among 443 manufacturers). Absolute volume is heavy-book.

What the Death-code reading shows for ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)

The standout signal for ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) is Death-code intensity: 7.77% of 53,055 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. 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 26,029 (49.1% of event_type total). Peak single-year volume reaches 14,943 reports across 12 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

53,055
Total Reports
4,124
Event-type Death
26,029
Injury Reports
20
Device Types

Event Types

Injury 26,029 (49.1%)
Malfunction 22,899 (43.2%)
Death 4,124 (7.8%)
3 (0.0%)

Patient Outcomes

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

24,016 (43.2%)
Required Intervention 22,112 (39.7%)
Death 4,122 (7.4%)
R 2,552 (4.6%)
Hospitalization 2,522 (4.5%)
Other 268 (0.5%)
O 21 (0.0%)
H 17 (0.0%)
Congenital Anomaly 11 (0.0%)
L 9 (0.0%)
Life Threatening 4 (0.0%)
S 3 (0.0%)

Yearly Trend

13
2013: 1
14
2014: 6
15
2015: 6,346
16
2016: 14,943
17
2017: 10,263
18
2018: 7,151
19
2019: 9,762
20
2020: 4,565
21
2021: 7
22
2022: 9
23
2023: 1
24
2024: 1