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2026 data FDA MAUDE openFDA FDA Class II

Stimulator, Nerve, Transcutaneous, For Pain Relief

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 §882.5890 (Neurology panel).

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FDA MAUDE casebook

openFDA event book Stimulator LIGHT-BOOK · MAUDE

#890 of 1000 · 500 reports · 1992–2026

  • BOOK 500 reports
  • RANK #890 of 1000
  • DEATH 4 death-typed
  • INJ 289 injury-typed
  • MALF 91 malfunction
  • SPAN 1992–2026
  • PEAK 2017: 58
  • PHOTO Bronchial Thermoplast…

Nearest event-volume peer: Bronchial Thermoplasty System (0 report gap)

Stimulator, Nerve, Transcutaneous, For Pain Relief sits #890 of 1000 among tracked device types with 500 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 sit below the device-type norm

Stimulator carries 18.2% MALFUNCTION-coded reports, 46.6pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.8% corpus 1.5% · below corpus mean (-0.7 pp)
  • INJ 57.8% corpus 30.3% · above corpus mean (+27.5 pp)
  • MALF 18.2% corpus 64.8% · below corpus mean (-46.6 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 24% of coded problems · Lead manufacturer UNK accounts for 100% of manufacturer-tagged reports · Top event location is 49% of location-tagged rows .

Stimulator in the event-volume neighbourhood

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

reports

What this shows Stimulator, Nerve, Transcutaneous, For Pain Relief carries 500 MAUDE reports, ranked #890 of 1000.

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

Event Types

Injury 289 (57.8%)
Other 96 (19.2%)
Malfunction 91 (18.2%)
20 (4.0%)
Death 4 (0.8%)

Patient Outcomes

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

Other 282 (52.3%)
112 (20.8%)
Required Intervention 68 (12.6%)
R 28 (5.2%)
Hospitalization 15 (2.8%)
Disability 12 (2.2%)
S 5 (0.9%)
O 4 (0.7%)
Death 4 (0.7%)
Life Threatening 3 (0.6%)
H 2 (0.4%)
L 2 (0.4%)
Congenital Anomaly 2 (0.4%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 98
Insufficient Device Problem Information 82
Unknown (for use when the device problem is not known) 64
Device Operates Differently Than Expected 28
Use of Device Problem 15
Improper or Incorrect Procedure or Method 14
Temperature Problem 10
Electrical /Electronic Property Problem 9
Inappropriate/Inadequate Shock/Stimulation 9
Output, high 9
Electrostatic Discharge 8
Patient-Device Incompatibility 8
Shock, electrical 8
Thermal Decomposition of Device 8
Charred 7
False claim 7
Loss of Power 6
Patient Device Interaction Problem 6
Power Conditioning Problem 6
Detachment Of Device Component 5

Yearly Trend

92
1992: 1
93
1993: 1
94
1994: 4
95
1995: 4
96
1996: 9
97
1997: 13
98
1998: 10
99
1999: 8
00
2000: 3
01
2001: 4
02
2002: 9
03
2003: 6
04
2004: 10
05
2005: 12
06
2006: 15
07
2007: 4
08
2008: 45
09
2009: 17
10
2010: 22
11
2011: 22
12
2012: 20
13
2013: 10
14
2014: 23
15
2015: 18
16
2016: 32
17
2017: 58
18
2018: 21
19
2019: 7
20
2020: 10
21
2021: 5
22
2022: 4
23
2023: 39
24
2024: 12
25
2025: 13
26
2026: 9

Reports fell to 13 in 2025, down from an average of 26 in the two years before.

Related Entities for Stimulator, Nerve, Transcutaneous, For Pain Relief

Top Manufacturers

UNK 13

Event Locations

244 (48.8%)
HOME 50 (10.0%)
OUTPATIENT TREATMENT FACILITY 43 (8.6%)
OTHER 40 (8.0%)
HOSPITAL 34 (6.8%)
I 34 (6.8%)
NO INFORMATION 23 (4.6%)
UNKNOWN 17 (3.4%)
INVALID DATA 8 (1.6%)
NOT APPLICABLE 5 (1.0%)
NURSING HOME 1 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.2%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Stimulator: 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 (500 here).

Bronchial Thermoplasty System 500 Prosthesis 499 Normothermic Machine Perfusion System For T… 498 Prosthesis 497

Similar death-typed counts

Nearest other device types by death-typed report count (4 here), distinct from the volume row.

Catheter, Urethral 4 Disinfectant, Medical Devices 4 Drill, Surgical, Ent Including Handpiece 4 Electrode 4

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

Disclaimer: MAUDE figures for Stimulator 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; 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.