MEDTRONIC NEUROMODULATION

FDA MAUDE device safety record · 2004–2026

What the Data Shows About MEDTRONIC NEUROMODULATION

MEDTRONIC NEUROMODULATION is associated with 57,580 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2004 through 2026. Of the total, 768 are coded as death reports and 31,776 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 20 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for MEDTRONIC NEUROMODULATION 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 31,776 reports (55.2% 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 23 years of MAUDE data, with the peak single-year volume reaching 4,836 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.

57,580
Total Reports
768
Death Reports
31,776
Injury Reports
20
Device Types

Event Types

Injury 31,776 (55.2%)
Malfunction 24,950 (43.3%)
Death 768 (1.3%)
58 (0.1%)
Other 28 (0.0%)

Patient Outcomes

24,509 (39.1%)
Required Intervention 21,929 (34.9%)
Other 5,050 (8.0%)
Hospitalization 4,592 (7.3%)
R 3,690 (5.9%)
Death 767 (1.2%)
L 557 (0.9%)
Life Threatening 482 (0.8%)
O 438 (0.7%)
H 326 (0.5%)
S 226 (0.4%)
Disability 171 (0.3%)
Congenital Anomaly 14 (0.0%)
D 10 (0.0%)

Yearly Trend

04
2004: 1
05
2005: 6
06
2006: 3
07
2007: 906
08
2008: 2,287
09
2009: 2,578
10
2010: 2,943
11
2011: 2,609
12
2012: 2,899
13
2013: 3,994
14
2014: 3,633
15
2015: 3,915
16
2016: 4,299
17
2017: 4,836
18
2018: 3,252
19
2019: 2,279
20
2020: 1,669
21
2021: 2,051
22
2022: 2,172
23
2023: 2,622
24
2024: 4,744
25
2025: 3,380
26
2026: 502

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.