BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

FDA MAUDE device safety record · 2008–2026

What the Data Shows About BOSTON SCIENTIFIC NEUROMODULATION CORPORATION

BOSTON SCIENTIFIC NEUROMODULATION CORPORATION is associated with 15,896 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2008 through 2026. Of the total, 37 are coded as death reports and 14,418 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 10 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for BOSTON SCIENTIFIC NEUROMODULATION CORPORATION should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Injury at 14,418 reports (90.7% of total). Patient-outcome categorizations are reported across 14 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 18 years of MAUDE data, with the peak single-year volume reaching 9,509 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

15,896
Total Reports
37
Death Reports
14,418
Injury Reports
10
Device Types

Event Types

Injury 14,418 (90.7%)
Malfunction 1,437 (9.0%)
Death 37 (0.2%)
2 (0.0%)
Other 2 (0.0%)

Patient Outcomes

Required Intervention 13,996 (85.0%)
1,198 (7.3%)
Hospitalization 429 (2.6%)
R 368 (2.2%)
Other 200 (1.2%)
H 162 (1.0%)
O 52 (0.3%)
Death 36 (0.2%)
L 8 (0.0%)
D 5 (0.0%)
S 5 (0.0%)
Life Threatening 4 (0.0%)
Disability 3 (0.0%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

08
2008: 515
09
2009: 1,272
10
2010: 1,251
11
2011: 5
12
2012: 3
14
2014: 1
15
2015: 3
16
2016: 1
17
2017: 3
18
2018: 6
19
2019: 7
20
2020: 11
21
2021: 17
22
2022: 25
23
2023: 59
24
2024: 2,041
25
2025: 9,509
26
2026: 1,167

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.