ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)

Manufacturer adverse-event records for ST. JUDE MEDICAL - NEUROMODULATION 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 · 2014–2026 · heavy-book · typical Death-code · injury-heavy

Injury-mix signature

ST. JUDE MEDICAL - NEUROMODULATION leans injury-heavy in event_type mix

Injury-coded event_type share is 97.6% (injury-heavy tercile) beside 0.22% Death-coded (typical). Volume band: heavy.

What the Injury-mix reading shows for ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)

The standout signal for ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) is Injury-mix: 97.6% Injury-coded (injury-heavy) beside 0.22% Death-coded, on a heavy-book footprint.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair ST. JUDE MEDICAL - NEUROMODULATION 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 15 device types, led in this extract by Injury at 58,313 (97.6% of event_type total). Peak single-year volume reaches 9,836 reports across 13 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

59,758
Total Reports
131
Event-type Death
58,313
Injury Reports
15
Device Types

Event Types

Injury 58,313 (97.6%)
Malfunction 1,313 (2.2%)
Death 131 (0.2%)
1 (0.0%)

Patient Outcomes

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

Other 57,118 (94.3%)
1,494 (2.5%)
Hospitalization 823 (1.4%)
O 643 (1.1%)
H 178 (0.3%)
Death 144 (0.2%)
Required Intervention 98 (0.2%)
R 34 (0.1%)
D 16 (0.0%)
Life Threatening 15 (0.0%)
L 8 (0.0%)
Disability 4 (0.0%)
S 3 (0.0%)
Congenital Anomaly 2 (0.0%)
C 1 (0.0%)

Yearly Trend

14
2014: 16
15
2015: 324
16
2016: 660
17
2017: 1,941
18
2018: 3,424
19
2019: 4,944
20
2020: 6,089
21
2021: 6,517
22
2022: 7,168
23
2023: 8,469
24
2024: 9,836
25
2025: 9,146
26
2026: 1,224