2026 data FDA MAUDE openFDA FDA Class III

Stimulator, Electrical, Implanted, For Essential Tremor

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

#471 of 1000 · 2,224 reports · 2016–2026

  • BOOK 2,224 reports
  • RANK #471 of 1000
  • DEATH 5 death-typed
  • INJ 734 injury-typed
  • MALF 1,485 malfunction
  • SPAN 2016–2026
  • PEAK 2023: 543
  • PHOTO Warmer

Nearest event-volume peer: Warmer, Blood, Non-Electromagnetic Radiation (5 report gap)

Stimulator, Electrical, Implanted, For Essential Tremor sits #471 of 1000 among tracked device types with 2,224 MAUDE reports spanning 2016–2026. 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 →

Injury-coded reports run above the device-type norm

Stimulator carries 33.0% INJURY-coded reports, 2.7pp 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 33.0% corpus 30.3% · above corpus mean (+2.7 pp)
  • MALF 66.8% corpus 64.8% · above corpus mean (+1.9 pp)

Lead product-problem code Connection Problem is 11% of coded problems · Lead manufacturer MEDTRONIC PUERTO RICO OPERATIONS CO. accounts for 80% of manufacturer-tagged reports · Top event location is 93% 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, Electrical, Implanted, For Essential Tremor carries 2,224 MAUDE reports, ranked #471 of 1000.

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

Event Types

Malfunction 1,485 (66.8%)
Injury 734 (33.0%)
Death 5 (0.2%)

Patient Outcomes

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

1,491 (65.8%)
Required Intervention 588 (25.9%)
Hospitalization 67 (3.0%)
Other 48 (2.1%)
H 25 (1.1%)
R 21 (0.9%)
O 7 (0.3%)
Death 5 (0.2%)
Disability 5 (0.2%)
Life Threatening 5 (0.2%)
L 2 (0.1%)
D 1 (0.0%)
S 1 (0.0%)

Top Product Problems

Connection Problem 391
Adverse Event Without Identified Device or Use Problem 380
Material Integrity Problem 341
Battery Problem 302
Failure to Deliver Energy 250
Insufficient Device Problem Information 246
Charging Problem 243
Communication or Transmission Problem 204
High impedance 198
Inappropriate/Inadequate Shock/Stimulation 198
Failure to Interrogate 127
Energy Output Problem 112
Failure to Power Up 98
Improper or Incorrect Procedure or Method 88
Electromagnetic Compatibility Problem 75
Break 70
Impedance Problem 69
Low impedance 66
Migration or Expulsion of Device 59
Delayed Charge Time 56

Yearly Trend

16
2016: 1
19
2019: 2
20
2020: 15
21
2021: 202
22
2022: 294
23
2023: 543
24
2024: 494
25
2025: 426
26
2026: 247

Reports in 2025 (426) held close to the prior two-year average of 519.

Related Entities for Stimulator, Electrical, Implanted, For Essential Tremor

Compare MEDTRONIC PUERTO RICO OPERATIONS CO. vs BOSTON SCIENTIFIC NEUROMODULATION CORPORATION →

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 (2,224 here).

Similar death-typed counts

Nearest other device types by death-typed report count (5 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.