What are FDA adverse event reports for Stimulator, Thalamic, Epilepsy, Implanted?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Stimulator, Thalamic, Epilepsy, Implanted, there are 367 total reports including 2 death reports and 173 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Stimulator, Thalamic, Epilepsy, Implanted?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Stimulator, Thalamic, Epilepsy, Implanted

Name: Stimulator, Thalamic, Epilepsy, Implanted - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book Stimulator, Thalamic, Epilepsy, Implanted LIGHT-BOOK · MAUDE

#976 of 1000 · 367 reports · 2018–2026

BOOK 367 reports
RANK #976 of 1000
DEATH 2 death-typed
INJ 173 injury-typed
MALF 192 malfunction
SPAN 2018–2026
PEAK 2025: 83
PHOTO Material, Impression

Nearest event-volume peer: Material, Impression (0 report gap)

Stimulator, Thalamic, Epilepsy, Implanted sits #976 of 1000 among tracked device types with 367 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 →

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 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
INJ 47.1% corpus 30.4% · above corpus mean (+16.7 pp)
MALF 52.3% corpus 64.5% · below corpus mean (-12.2 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 75% of location-tagged rows .

Cardiac Cathe…

371
Reagent Red B…

370
Stimulator (this)

367
Material

367
Probe

365
Crutch

363

What this shows Stimulator, Thalamic, Epilepsy, Implanted carries 367 MAUDE reports, ranked #976 of 1000.

Event Types

Malfunction 192 (52.3%)

Injury 173 (47.1%)

Death 2 (0.5%)

Patient Outcomes

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

188 (47.4%)

Required Intervention 107 (27.0%)

Hospitalization 37 (9.3%)

Other 22 (5.5%)

R 13 (3.3%)

Life Threatening 9 (2.3%)

H 7 (1.8%)

O 5 (1.3%)

L 3 (0.8%)

S 2 (0.5%)

Death 2 (0.5%)

Disability 2 (0.5%)

Yearly Trend

2018: 8

2019: 32

2020: 18

2021: 36

2022: 44

2023: 62

2024: 73

2025: 83

2026: 11

Top Manufacturers

MEDTRONIC PUERTO RICO OPERATIONS CO. 240

MEDTRONIC NEUROMODULATION 89

MEDTRONIC EUROPE SARL 14

MPRI 9

MEDTRONIC MED REL MEDTRONIC PUERTO RICO 6

MEDTRONIC 2

MEDTRONIC PUERTO RICO VILLALBA 2

MEDTRONIC, INC. 1

Event Locations

277 (75.5%)

I 89 (24.3%)

HOSPITAL 1 (0.3%)

Compare MEDTRONIC PUERTO RICO OPERATIONS CO. vs MEDTRONIC NEUROMODULATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Stimulator, Thalamic, Epilepsy, Implanted, 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 (367 here).

Material, Impression 367 Probe, Blood-Flow, Extravascular 365 Reagent Red Blood Cells 370 Cardiac Catheterization Kit 371

Similar death-typed counts

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

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Analyzer, Chemistry Clinical Use 2 Bed, Pediatric Open Hospital 2

Read our methodology - how this data is sourced, computed, and verified.

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.

Stimulator, Thalamic, Epilepsy, Implanted

Event-type mix vs corpus