2026 data FDA MAUDE openFDA FDA Class III

Stimulator, Thalamic, Epilepsy, Implanted

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, Thalamic, Epilepsy, Implanted LIGHT-BOOK · MAUDE

#967 of 1000 · 403 reports · 2018–2026

  • BOOK 403 reports
  • RANK #967 of 1000
  • DEATH 2 death-typed
  • INJ 187 injury-typed
  • MALF 214 malfunction
  • SPAN 2018–2026
  • PEAK 2025: 83
  • PHOTO Methyl Methacrylate F…

Nearest event-volume peer: Methyl Methacrylate For Cranioplasty (0 report gap)

Stimulator, Thalamic, Epilepsy, Implanted sits #967 of 1000 among tracked device types with 403 MAUDE reports spanning 2018–2026. 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, Thalamic, Epilepsy, Implanted carries 46.4% INJURY-coded reports, 16.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 46.4% corpus 30.3% · above corpus mean (+16.1 pp)
  • MALF 53.1% corpus 64.8% · below corpus mean (-11.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 21% of coded problems · Lead manufacturer MEDTRONIC PUERTO RICO OPERATIONS CO. accounts for 66% of manufacturer-tagged reports · Top event location is 78% of location-tagged rows .

Stimulator, Thalamic, Epilepsy, Implanted in the event-volume neighbourhood

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

reports

What this shows Stimulator, Thalamic, Epilepsy, Implanted carries 403 MAUDE reports, ranked #967 of 1000.

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

Event Types

Malfunction 214 (53.1%)
Injury 187 (46.4%)
Death 2 (0.5%)

Patient Outcomes

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

209 (48.0%)
Required Intervention 116 (26.7%)
Hospitalization 39 (9.0%)
Other 23 (5.3%)
R 15 (3.4%)
Life Threatening 9 (2.1%)
H 8 (1.8%)
L 5 (1.1%)
O 5 (1.1%)
S 2 (0.5%)
Death 2 (0.5%)
Disability 2 (0.5%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 115
High impedance 77
Insufficient Device Problem Information 52
Battery Problem 38
Failure to Deliver Energy 36
Break 30
Communication or Transmission Problem 23
Malposition of Device 19
Charging Problem 18
Low impedance 18
Migration or Expulsion of Device 18
Impedance Problem 15
Display or Visual Feedback Problem 13
Failure to Interrogate 13
Failure to Power Up 11
Inappropriate/Inadequate Shock/Stimulation 11
Material Integrity Problem 11
Unintended Collision 11
Connection Problem 10
Energy Output Problem 10

Yearly Trend

18
2018: 8
19
2019: 32
20
2020: 18
21
2021: 36
22
2022: 44
23
2023: 62
24
2024: 73
25
2025: 83
26
2026: 47

Reports in 2025 (83) held close to the prior two-year average of 68.

Related Entities for Stimulator, Thalamic, Epilepsy, Implanted

Compare MEDTRONIC PUERTO RICO OPERATIONS CO. vs MEDTRONIC NEUROMODULATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Stimulator, Thalamic, Epilepsy, Implanted: 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 (403 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Disclaimer: MAUDE figures for Stimulator, Thalamic, Epilepsy, Implanted 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, Thalamic, Epilepsy, Implanted; 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.