2026 data FDA MAUDE openFDA

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

#479 of 1000 · 2,042 reports · 2016–2026

  • BOOK 2,042 reports
  • RANK #479 of 1000
  • DEATH 5 death-typed
  • INJ 646 injury-typed
  • MALF 1,391 malfunction
  • SPAN 2016–2026
  • PEAK 2023: 543
  • PHOTO Tray

Nearest event-volume peer: Tray, Surgical, Instrument (4 report gap)

Stimulator, Electrical, Implanted, For Essential Tremor sits #479 of 1000 among tracked device types with 2,042 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 31.6% corpus 30.4% · above corpus mean (+1.2 pp)
  • MALF 68.1% corpus 64.5% · above corpus mean (+3.6 pp)

Lead product-problem code Connection Problem is 12% 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 2,042 MAUDE reports, ranked #479 of 1000.

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

Event Types

Malfunction 1,391 (68.1%)
Injury 646 (31.6%)
Death 5 (0.2%)

Patient Outcomes

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

1,395 (67.0%)
Required Intervention 524 (25.2%)
Hospitalization 58 (2.8%)
Other 44 (2.1%)
H 21 (1.0%)
R 19 (0.9%)
O 6 (0.3%)
Death 5 (0.2%)
Disability 4 (0.2%)
Life Threatening 4 (0.2%)
D 1 (0.0%)
L 1 (0.0%)
S 1 (0.0%)

Top Product Problems

Connection Problem 393
Material Integrity Problem 344
Adverse Event Without Identified Device or Use Problem 338
Battery Problem 266
Charging Problem 227
Insufficient Information 217
Failure to Deliver Energy 213
Communication or Transmission Problem 189
Inappropriate/Inadequate Shock/Stimulation 187
High impedance 171
Failure to Interrogate 119
Energy Output Problem 105
Failure to Power Up 98
Improper or Incorrect Procedure or Method 83
Break 67
Electromagnetic Compatibility Problem 66
Impedance Problem 65
Low impedance 61
Migration or Expulsion of Device 55
Malposition of Device 52

Yearly Trend

16
2016: 1
19
2019: 2
20
2020: 15
21
2021: 202
22
2022: 294
23
2023: 543
24
2024: 493
25
2025: 428
26
2026: 64

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

Compare MEDTRONIC PUERTO RICO OPERATIONS CO. vs MEDTRONIC MED REL MEDTRONIC PUERTO RICO →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Stimulator, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (2,042 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.