2026 data FDA MAUDE openFDA FDA Class III

Stimulator, Low Electric Field, Tumor Treatment

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 MAUDE casebook

openFDA event book Stimulator LIGHT-BOOK · MAUDE

#738 of 1000 · 790 reports · 2012–2026

  • BOOK 790 reports
  • RANK #738 of 1000
  • DEATH 27 death-typed
  • INJ 747 injury-typed
  • MALF 1 malfunction
  • SPAN 2012–2026
  • PEAK 2025: 245
  • PHOTO Mesh

Nearest event-volume peer: Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed (3 report gap)

Stimulator, Low Electric Field, Tumor Treatment sits #738 of 1000 among tracked device types with 790 MAUDE reports spanning 2012–2026. 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 → · Similar-volume device →

Malfunction reports sit below the device-type norm

Stimulator carries 0.1% MALFUNCTION-coded reports, 64.7pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.4% corpus 1.5% · above corpus mean (+1.9 pp)
  • INJ 94.6% corpus 30.3% · above corpus mean (+64.3 pp)
  • MALF 0.1% corpus 64.8% · below corpus mean (-64.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 97% of coded problems · Top event location is 87% 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, Low Electric Field, Tumor Treatment carries 790 MAUDE reports, ranked #738 of 1000.

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

Event Types

Injury 747 (94.6%)
Death 27 (3.4%)
Other 15 (1.9%)
Malfunction 1 (0.1%)

Patient Outcomes

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

Required Intervention 469 (48.7%)
Hospitalization 200 (20.8%)
R 122 (12.7%)
Other 75 (7.8%)
H 46 (4.8%)
Death 28 (2.9%)
O 21 (2.2%)
Disability 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 764
Insufficient Device Problem Information 19
Connection Problem 1
Device Operates Differently Than Expected 1
Device-Device Incompatibility 1
Improper or Incorrect Procedure or Method 1
Inappropriate/Inadequate Shock/Stimulation 1
Material Erosion 1
Patient-Device Incompatibility 1
Use of Device Problem 1

Yearly Trend

12
2012: 12
13
2013: 22
14
2014: 11
15
2015: 23
16
2016: 9
17
2017: 12
18
2018: 23
19
2019: 21
20
2020: 30
21
2021: 32
22
2022: 26
23
2023: 29
24
2024: 156
25
2025: 245
26
2026: 139

Reports rose to 245 in 2025, up from an average of 93 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Stimulator, Low Electric Field, Tumor Treatment

Event Locations

686 (86.8%)
I 98 (12.4%)
HOME 3 (0.4%)
NO INFORMATION 2 (0.3%)
HOSPITAL 1 (0.1%)

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 (790 here).

Similar death-typed counts

Nearest other device types by death-typed report count (27 here), distinct from the volume row.

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.