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2026 data FDA MAUDE openFDA FDA Class II

Stimulator, Muscle, Powered

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 §890.5850 (Physical Medicine panel).

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FDA MAUDE casebook

openFDA event book Stimulator, Muscle, Powered LIGHT-BOOK · MAUDE

#784 of 1000 · 678 reports · 1992–2026

  • BOOK 678 reports
  • RANK #784 of 1000
  • DEATH 1 death-typed
  • INJ 347 injury-typed
  • MALF 181 malfunction
  • SPAN 1992–2026
  • PEAK 2008: 213
  • PHOTO Tube

Nearest event-volume peer: Tube, Drainage, Suprapubic (1 report gap)

Stimulator, Muscle, Powered sits #784 of 1000 among tracked device types with 678 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, Muscle, Powered carries 26.7% MALFUNCTION-coded reports, 38.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 51.2% corpus 30.3% · above corpus mean (+20.9 pp)
  • MALF 26.7% corpus 64.8% · below corpus mean (-38.1 pp)

Lead product-problem code Unknown (for use when the device problem is not known) is 37% of coded problems · Lead manufacturer UNK accounts for 100% of manufacturer-tagged reports · Top event location is 74% of location-tagged rows .

Stimulator, Muscle, Powered in the event-volume neighbourhood

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

reports

What this shows Stimulator, Muscle, Powered carries 678 MAUDE reports, ranked #784 of 1000.

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

Event Types

Injury 347 (51.2%)
Malfunction 181 (26.7%)
Other 125 (18.4%)
24 (3.5%)
Death 1 (0.1%)

Patient Outcomes

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

Other 382 (54.1%)
165 (23.4%)
Required Intervention 103 (14.6%)
Disability 15 (2.1%)
Hospitalization 13 (1.8%)
R 10 (1.4%)
S 7 (1.0%)
O 6 (0.8%)
Life Threatening 3 (0.4%)
L 1 (0.1%)
Death 1 (0.1%)

Top Product Problems

Unknown (for use when the device problem is not known) 224
Output, high 59
Insufficient Device Problem Information 47
Self-Activation or Keying 39
Power Conditioning Problem 24
Device Operates Differently Than Expected 22
Shock, electrical 22
Use of Device Problem 19
Adverse Event Without Identified Device or Use Problem 17
Output above Specifications 13
Reaction 13
Inappropriate/Inadequate Shock/Stimulation 12
Nonstandard Device 12
Other (for use when an appropriate device code cannot be identified) 12
Overheating of Device 12
Electrical /Electronic Property Problem 11
Thermal Decomposition of Device 11
Loss of Power 10
Temperature Problem 10
Charred 9

Yearly Trend

92
1992: 1
93
1993: 1
94
1994: 8
95
1995: 7
96
1996: 7
97
1997: 10
98
1998: 2
99
1999: 3
00
2000: 6
01
2001: 14
02
2002: 44
03
2003: 13
04
2004: 9
05
2005: 4
06
2006: 11
07
2007: 11
08
2008: 213
09
2009: 150
10
2010: 14
11
2011: 25
12
2012: 16
13
2013: 6
14
2014: 19
15
2015: 11
16
2016: 8
17
2017: 2
18
2018: 3
19
2019: 10
20
2020: 13
21
2021: 3
22
2022: 4
23
2023: 8
24
2024: 5
25
2025: 10
26
2026: 7

Reports rose to 10 in 2025, up from an average of 7 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Stimulator, Muscle, Powered

Top Manufacturers

UNK 17

Event Locations

502 (74.0%)
HOME 38 (5.6%)
HOSPITAL 32 (4.7%)
OUTPATIENT TREATMENT FACILITY 27 (4.0%)
I 23 (3.4%)
UNKNOWN 22 (3.2%)
NO INFORMATION 16 (2.4%)
OTHER 7 (1.0%)
INVALID DATA 6 (0.9%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.3%)
NOT APPLICABLE 1 (0.1%)
NURSING HOME 1 (0.1%)
REHABILITATION CENTER 1 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Stimulator, Muscle, Powered: 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 (678 here).

Tube, Drainage, Suprapubic 677 Needle, Dental 682 Bit, Surgical 683 Forceps, General & Plastic Surgery 673

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, Muscle, Powered 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, Muscle, Powered; 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.