2026 data FDA MAUDE openFDA FDA Class II

Stimulator, Nerve

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §874.1820 (Ear, Nose, Throat panel).

FDA MAUDE casebook

openFDA event book Stimulator, Nerve LIGHT-BOOK · MAUDE

#317 of 1000 · 5,083 reports · 1992–2026

  • BOOK 5,083 reports
  • RANK #317 of 1000
  • DEATH 11 death-typed
  • INJ 806 injury-typed
  • MALF 4,240 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 1,156
  • PHOTO Accessories

Nearest event-volume peer: Accessories, Cleaning, For Endoscope (37 report gap)

Stimulator, Nerve sits #317 of 1000 among tracked device types with 5,083 MAUDE reports spanning 1992–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports run above the device-type norm

Stimulator, Nerve carries 83.4% MALFUNCTION-coded reports, 18.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 15.9% corpus 30.3% · below corpus mean (-14.4 pp)
  • MALF 83.4% corpus 64.8% · above corpus mean (+18.6 pp)

Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 27% of coded problems · Lead manufacturer MEDTRONIC XOMED INC. accounts for 87% of manufacturer-tagged reports · Top event location is 66% of location-tagged rows .

Stimulator, Nerve in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Stimulator, Nerve carries 5,083 MAUDE reports, ranked #317 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 4,240 (83.4%)
Injury 806 (15.9%)
Other 15 (0.3%)
11 (0.2%)
Death 11 (0.2%)

Patient Outcomes

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

4,216 (81.8%)
Required Intervention 414 (8.0%)
Other 288 (5.6%)
Disability 59 (1.1%)
Hospitalization 44 (0.9%)
Life Threatening 41 (0.8%)
R 36 (0.7%)
S 16 (0.3%)
O 15 (0.3%)
L 10 (0.2%)
Death 10 (0.2%)
H 8 (0.2%)

Top Product Problems

Incorrect, Inadequate or Imprecise Result or Readings 1,348
Use of Device Problem 575
Unintended Deflation 447
Device Operates Differently Than Expected 424
False Negative Result 357
Inappropriate Audible Prompt/Feedback 262
Failure to Sense 199
Device Sensing Problem 196
Adverse Event Without Identified Device or Use Problem 153
Break 146
Leak/Splash 124
Obstruction of Flow 124
Unable to Obtain Readings 110
Noise, Audible 67
Air Leak 65
Failure to Power Up 65
False Positive Result 62
Material Puncture/Hole 62
Inflation Problem 59
Sensing Intermittently 59

Yearly Trend

92
1992: 1
94
1994: 1
97
1997: 2
98
1998: 1
00
2000: 9
01
2001: 5
02
2002: 2
04
2004: 3
05
2005: 1
06
2006: 5
07
2007: 5
08
2008: 5
09
2009: 22
10
2010: 26
11
2011: 55
12
2012: 187
13
2013: 270
14
2014: 137
15
2015: 202
16
2016: 145
17
2017: 117
18
2018: 250
19
2019: 314
20
2020: 238
21
2021: 197
22
2022: 247
23
2023: 390
24
2024: 748
25
2025: 1,156
26
2026: 342

Reports rose to 1,156 in 2025, up from an average of 569 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Stimulator, Nerve

Event Locations

3,373 (66.4%)
I 1,532 (30.1%)
HOSPITAL 144 (2.8%)
NO INFORMATION 21 (0.4%)
OTHER 5 (0.1%)
AMBULATORY SURGICAL FACILITY 4 (0.1%)
OPERATING ROOM 2 (0.0%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)

Compare MEDTRONIC XOMED INC. vs MEDTRONIC XOMED, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Stimulator, Nerve: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (5,083 here).

Similar death-typed counts

Nearest other device types by death-typed report count (11 here), distinct from the volume row.

Disclaimer: MAUDE figures for Stimulator, Nerve are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Stimulator, Nerve; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.