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2026 data FDA MAUDE openFDA FDA Class III

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.

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FDA MAUDE casebook

openFDA event book Stimulator MID-BOOK · MAUDE

#69 of 1000 · 51,898 reports · 1998–2026

  • BOOK 51,898 reports
  • RANK #69 of 1000
  • DEATH 2,917 death-typed
  • INJ 18,399 injury-typed
  • MALF 30,459 malfunction
  • SPAN 1998–2026
  • PEAK 2013: 3,809
  • PHOTO Drug Eluting Permanen…

Nearest event-volume peer: Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode (308 report gap)

Stimulator, Autonomic Nerve, Implanted For Epilepsy sits #69 of 1000 among tracked device types with 51,898 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 →

Malfunction reports sit below the device-type norm

Stimulator carries 58.7% MALFUNCTION-coded reports, 6.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 5.6% corpus 1.5% · above corpus mean (+4.1 pp)
  • INJ 35.5% corpus 30.3% · above corpus mean (+5.2 pp)
  • MALF 58.7% corpus 64.8% · below corpus mean (-6.1 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 22% of coded problems · Lead manufacturer CYBERONICS, INC. accounts for 57% of manufacturer-tagged reports · Top event location OTHER is 63% 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 51,898 MAUDE reports, ranked #69 of 1000.

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

Event Types

Malfunction 30,459 (58.7%)
Injury 18,399 (35.5%)
Death 2,917 (5.6%)
Other 83 (0.2%)
40 (0.1%)

Patient Outcomes

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

28,406 (51.0%)
Required Intervention 10,519 (18.9%)
Other 5,259 (9.4%)
Hospitalization 3,210 (5.8%)
Death 2,847 (5.1%)
R 2,709 (4.9%)
Life Threatening 1,092 (2.0%)
Disability 492 (0.9%)
O 439 (0.8%)
L 345 (0.6%)
S 210 (0.4%)
H 171 (0.3%)
D 19 (0.0%)
Congenital Anomaly 5 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 11,231
High impedance 9,413
Insufficient Device Problem Information 4,707
Fracture 4,336
Device remains implanted 2,557
Explanted 2,414
Device Operates Differently Than Expected 2,341
Battery Problem 1,797
Unknown (for use when the device problem is not known) 1,491
Replace 1,333
Failure to Interrogate 1,287
Use of Incorrect Control/Treatment Settings 1,198
Device Displays Incorrect Message 1,091
Break 1,015
Communication or Transmission Problem 817
Device Inoperable 778
No Display/Image 767
Low impedance 726
Premature End-of-Life Indicator 689
Programming Issue 665

Yearly Trend

98
1998: 5
99
1999: 16
00
2000: 27
01
2001: 665
02
2002: 573
03
2003: 903
04
2004: 1,146
05
2005: 902
06
2006: 390
07
2007: 1,890
08
2008: 2,758
09
2009: 2,686
10
2010: 2,747
11
2011: 3,039
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: 892

Reports in 2025 (1,455) held close to the prior two-year average of 1,644.

Related Entities for Stimulator, Autonomic Nerve, Implanted For Epilepsy

Top Manufacturers

CYBERONICS, INC. 27,753
LIVANOVA USA, INC. 9,515
CYBERONICS - HOUSTON 6,662
CYBERONICS INC 4,750
CYBERONICS INC. 233
CYBERONICS, INC 39

Event Locations

OTHER 32,683 (63.0%)
18,840 (36.3%)
I 150 (0.3%)
HOSPITAL 99 (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%)
0 3 (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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Stimulator: 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 (51,898 here).

Drug Eluting Permanent Left Ventricular Pac… 52,206 Syringe, Piston 52,759 Generator, Oxygen, Portable 52,785 Stimulator 52,959

Similar death-typed counts

Nearest other device types by death-typed report count (2,917 here), distinct from the volume row.

Permanent Defibrillator Electrodes 3,081 Dialyzer 2,583 Set 2,402 System, Peritoneal, Automatic Delivery 3,434

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

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.