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2026 data FDA MAUDE openFDA FDA Class II

Stimulator, Electrical, Evoked Response

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 §882.1870 (Neurology panel).

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FDA MAUDE casebook

openFDA event book Stimulator, Electrical, Evoked Response LIGHT-BOOK · MAUDE

#384 of 1000 · 3,228 reports · 1994–2026

  • BOOK 3,228 reports
  • RANK #384 of 1000
  • DEATH 1 death-typed
  • INJ 110 injury-typed
  • MALF 3,102 malfunction
  • SPAN 1994–2026
  • PEAK 2025: 1,042
  • PHOTO Unit

Nearest event-volume peer: Unit, Cryosurgical, Accessories (0 report gap)

Stimulator, Electrical, Evoked Response sits #384 of 1000 among tracked device types with 3,228 MAUDE reports spanning 1994–2026. 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, Electrical, Evoked Response carries 96.1% MALFUNCTION-coded reports, 31.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 3.4% corpus 30.3% · below corpus mean (-26.9 pp)
  • MALF 96.1% corpus 64.8% · above corpus mean (+31.3 pp)

Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 43% of coded problems · Lead manufacturer MEDTRONIC XOMED INC. accounts for 92% of manufacturer-tagged reports · Top event location is 88% of location-tagged rows .

Stimulator, Electrical, Evoked Response in the event-volume neighbourhood

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

reports

What this shows Stimulator, Electrical, Evoked Response carries 3,228 MAUDE reports, ranked #384 of 1000.

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

Event Types

Malfunction 3,102 (96.1%)
Injury 110 (3.4%)
Other 12 (0.4%)
3 (0.1%)
Death 1 (0.0%)

Patient Outcomes

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

2,970 (95.0%)
Other 85 (2.7%)
Required Intervention 24 (0.8%)
Disability 14 (0.4%)
Hospitalization 7 (0.2%)
S 6 (0.2%)
H 4 (0.1%)
R 4 (0.1%)
L 3 (0.1%)
O 3 (0.1%)
Life Threatening 3 (0.1%)
Death 2 (0.1%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Incorrect, Inadequate or Imprecise Result or Readings 1,581
Use of Device Problem 409
Inappropriate Audible Prompt/Feedback 286
False Negative Result 268
Device Operates Differently Than Expected 158
Failure to Power Up 131
Computer Software Problem 110
False Positive Result 101
Connection Problem 78
Unable to Obtain Readings 77
Application Program Freezes or Fails to Launch 63
Incomplete or Inadequate Connection 61
Problem with Software Installation 54
Break 52
Signal Artifact/Noise 48
Device Sensing Problem 45
Battery Problem 42
Electrical /Electronic Property Problem 40
Adverse Event Without Identified Device or Use Problem 31
Failure to Sense 24

Yearly Trend

94
1994: 3
97
1997: 2
99
1999: 1
02
2002: 1
03
2003: 3
04
2004: 1
05
2005: 2
06
2006: 2
07
2007: 2
08
2008: 1
09
2009: 1
10
2010: 4
11
2011: 10
12
2012: 44
13
2013: 89
14
2014: 25
15
2015: 22
16
2016: 20
17
2017: 60
18
2018: 58
19
2019: 94
20
2020: 65
21
2021: 55
22
2022: 45
23
2023: 150
24
2024: 854
25
2025: 1,042
26
2026: 572

Reports rose to 1,042 in 2025, up from an average of 502 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Stimulator, Electrical, Evoked Response

Top Manufacturers

MEDTRONIC XOMED INC. 2,824
NIHON KOHDEN CORPORATION 100
MEDTRONIC XOMED, INC. 97
Medtronic Xomed Inc. 19
MEDTRONIC SOFAMOR DANEK USA, INC 10
MEDTRONIC XOMED, INC 9

Event Locations

2,840 (88.0%)
I 289 (9.0%)
HOSPITAL 80 (2.5%)
NO INFORMATION 12 (0.4%)
INVALID DATA 2 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
OTHER 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare MEDTRONIC XOMED INC. vs NIHON KOHDEN CORPORATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Stimulator, Electrical, Evoked Response: 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 (3,228 here).

Unit, Cryosurgical, Accessories 3,228 Monitor, Bed Patient 3,238 Chair, With Casters 3,241 Integrated Continuous Glucose Monitoring Sy… 3,214

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Stimulator, Electrical, Evoked Response 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, Electrical, Evoked Response; 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.