BOSTON SCIENTIFIC NEUROMODULATION

Manufacturer adverse-event records for BOSTON SCIENTIFIC 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 · 2008–2024 · heavy-book · typical Death-code · injury-heavy

Injury-mix signature

BOSTON SCIENTIFIC NEUROMODULATION leans injury-heavy in event_type mix

Injury-coded event_type share is 90.0% (injury-heavy tercile) beside 0.47% Death-coded (typical). Volume band: heavy.

What the Injury-mix reading shows for BOSTON SCIENTIFIC NEUROMODULATION

The standout signal for BOSTON SCIENTIFIC NEUROMODULATION is Injury-mix: 90.0% Injury-coded (injury-heavy) beside 0.47% Death-coded, on a heavy-book footprint.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair BOSTON SCIENTIFIC 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 8 device types, led in this extract by Injury at 55,691 (90.0% of event_type total). Peak single-year volume reaches 6,946 reports across 17 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

61,866
Total Reports
289
Event-type Death
55,691
Injury Reports
8
Device Types

Event Types

Injury 55,691 (90.0%)
Malfunction 5,886 (9.5%)
Death 289 (0.5%)

Patient Outcomes

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

Required Intervention 54,258 (84.8%)
4,974 (7.8%)
Hospitalization 1,808 (2.8%)
R 1,736 (2.7%)
Other 428 (0.7%)
H 293 (0.5%)
Death 288 (0.4%)
O 123 (0.2%)
S 41 (0.1%)
Disability 22 (0.0%)
Congenital Anomaly 15 (0.0%)
D 14 (0.0%)
L 10 (0.0%)
Life Threatening 9 (0.0%)

Yearly Trend

08
2008: 3
09
2009: 4
10
2010: 601
11
2011: 2,085
12
2012: 2,238
13
2013: 2,481
14
2014: 2,670
15
2015: 2,932
16
2016: 3,425
17
2017: 3,953
18
2018: 4,297
19
2019: 6,551
20
2020: 5,348
21
2021: 6,172
22
2022: 6,257
23
2023: 6,946
24
2024: 5,903