PlainHospital
2026 data FDA MAUDE openFDA FDA Class III

Implanted Brain Stimulator For Epilepsy

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.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Implanted Brain Stimulator For Epilepsy LIGHT-BOOK · MAUDE

#763 of 1000 · 746 reports · 2014–2026

  • BOOK 746 reports
  • RANK #763 of 1000
  • DEATH 2 death-typed
  • INJ 594 injury-typed
  • MALF 149 malfunction
  • SPAN 2014–2026
  • PEAK 2025: 89
  • PHOTO Device

Nearest event-volume peer: Device, Intravascular Catheter Securement (3 report gap)

Implanted Brain Stimulator For Epilepsy sits #763 of 1000 among tracked device types with 746 MAUDE reports spanning 2014–2026. 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

Implanted Brain Stimulator For Epilepsy carries 79.6% INJURY-coded reports, 49.3pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 79.6% corpus 30.3% · above corpus mean (+49.3 pp)
  • MALF 20.0% corpus 64.8% · below corpus mean (-44.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 57% of coded problems · Lead manufacturer UNK accounts for 100% of manufacturer-tagged reports · Top event location is 56% of location-tagged rows .

Implanted Brain Stimulator For Epilepsy in the event-volume neighbourhood

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

reports

What this shows Implanted Brain Stimulator For Epilepsy carries 746 MAUDE reports, ranked #763 of 1000.

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

Event Types

Injury 594 (79.6%)
Malfunction 149 (20.0%)
Death 2 (0.3%)
1 (0.1%)

Patient Outcomes

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

Hospitalization 318 (22.5%)
R 284 (20.1%)
Other 270 (19.1%)
O 198 (14.0%)
H 158 (11.2%)
Required Intervention 144 (10.2%)
L 12 (0.9%)
S 8 (0.6%)
D 7 (0.5%)
4 (0.3%)
Life Threatening 3 (0.2%)
Death 2 (0.1%)
Disability 2 (0.1%)
Congenital Anomaly 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 510
Signal Artifact/Noise 97
High impedance 67
Impedance Problem 43
Failure to Interrogate 37
Break 33
Communication or Transmission Problem 29
Insufficient Device Problem Information 19
Premature Discharge of Battery 11
Failure to Transmit Record 8
Appropriate Device Problem Term/Code Not Available 7
Device Remains Activated 5
Fracture 5
Battery Problem 4
Positioning Problem 4
Migration 3
Therapeutic or Diagnostic Output Failure 3
Deformation Due to Compressive Stress 2
Detachment of Device or Device Component 2
Device Slipped 2

Yearly Trend

14
2014: 15
15
2015: 36
16
2016: 28
17
2017: 63
18
2018: 54
19
2019: 59
20
2020: 66
21
2021: 57
22
2022: 49
23
2023: 67
24
2024: 86
25
2025: 89
26
2026: 77

Reports in 2025 (89) held close to the prior two-year average of 77.

Related Entities for Implanted Brain Stimulator For Epilepsy

Top Manufacturers

UNK 1

Event Locations

416 (55.8%)
I 324 (43.4%)
NO INFORMATION 5 (0.7%)
HOSPITAL 1 (0.1%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Implanted Brain Stimulator For Epilepsy: 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 (746 here).

Device, Intravascular Catheter Securement 749 Osteotome 749 Catheter, Balloon Type 751 Extractor, Vacuum, Fetal 751

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 Bed, Pediatric Open Hospital 2 Blade 2

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

Disclaimer: MAUDE figures for Implanted Brain Stimulator For Epilepsy 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 Implanted Brain Stimulator For Epilepsy; 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.