2026 data FDA MAUDE openFDA

Stimulator, Autonomic Nerve, Implanted 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.

FDA MAUDE casebook

openFDA event book Stimulator MID-BOOK · MAUDE

#66 of 1000 · 51,263 reports · 1998–2026

  • BOOK 51,263 reports
  • RANK #66 of 1000
  • DEATH 2,889 death-typed
  • INJ 18,131 injury-typed
  • MALF 30,121 malfunction
  • SPAN 1998–2026
  • PEAK 2013: 3,809
  • PHOTO Syringe, Piston

Nearest event-volume peer: Syringe, Piston (229 report gap)

Stimulator, Autonomic Nerve, Implanted For Epilepsy sits #66 of 1000 among tracked device types with 51,263 MAUDE reports spanning 1998–2026. 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 5.6% corpus 1.5% · above corpus mean (+4.1 pp)
  • INJ 35.4% corpus 30.4% · above corpus mean (+4.9 pp)
  • MALF 58.8% corpus 64.5% · below corpus mean (-5.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 45% of coded problems · Lead manufacturer CYBERONICS, INC. accounts for 57% of manufacturer-tagged reports · Top event location OTHER is 64% 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, Autonomic Nerve, Implanted For Epilepsy carries 51,263 MAUDE reports, ranked #66 of 1000.

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

Event Types

Malfunction 30,121 (58.8%)
Injury 18,131 (35.4%)
Death 2,889 (5.6%)
Other 82 (0.2%)
40 (0.1%)

Patient Outcomes

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

28,118 (51.0%)
Required Intervention 10,432 (18.9%)
Other 5,132 (9.3%)
Hospitalization 3,155 (5.7%)
Death 2,825 (5.1%)
R 2,699 (4.9%)
Life Threatening 1,089 (2.0%)
Disability 481 (0.9%)
O 433 (0.8%)
L 342 (0.6%)
S 206 (0.4%)
H 157 (0.3%)
D 15 (0.0%)
Congenital Anomaly 5 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 9,376
Fracture 3,626
High impedance 2,656
Premature End-of-Life Indicator 624
Low impedance 502
Insufficient Information 493
Corroded 379
Premature Discharge of Battery 371
Device Contamination with Body Fluid 360
Naturally Worn 294
Mechanical Problem 279
Communication or Transmission Problem 261
Failure to Interrogate 253
Device Operates Differently Than Expected 244
Energy Output Problem 201
Computer Software Problem 191
Electrical Shorting 165
Battery Problem 148
Device Displays Incorrect Message 145
Incomplete or Inadequate Connection 123

Yearly Trend

98
1998: 5
99
1999: 16
00
2000: 27
01
2001: 665
02
2002: 573
03
2003: 900
04
2004: 1,144
05
2005: 902
06
2006: 389
07
2007: 1,889
08
2008: 2,757
09
2009: 2,686
10
2010: 2,747
11
2011: 3,038
12
2012: 3,364
13
2013: 3,809
14
2014: 3,365
15
2015: 3,265
16
2016: 2,854
17
2017: 2,074
18
2018: 2,317
19
2019: 2,432
20
2020: 1,688
21
2021: 1,764
22
2022: 1,584
23
2023: 1,764
24
2024: 1,524
25
2025: 1,455
26
2026: 266

Related Entities for Stimulator, Autonomic Nerve, Implanted For Epilepsy

Event Locations

OTHER 32,686 (63.8%)
18,206 (35.5%)
I 150 (0.3%)
HOSPITAL 98 (0.2%)
NO INFORMATION 39 (0.1%)
HOME 25 (0.0%)
OPERATING ROOM 24 (0.0%)
UNKNOWN 20 (0.0%)
CLINIC - WALK IN, OTHER 5 (0.0%)
INVALID DATA 4 (0.0%)
EXAMINATION ROOM 2 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
BLOOD BANK 1 (0.0%)
OUTDOORS 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare CYBERONICS, INC. vs LIVANOVA USA, INC. →

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 (51,263 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2,889 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.