2026 data FDA MAUDE openFDA

Stimulator, Autonomic Nerve, Implanted (Depression)

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, Autonomic Nerve, Implanted LIGHT-BOOK · MAUDE

#446 of 1000 · 2,349 reports · 2004–2026

  • BOOK 2,349 reports
  • RANK #446 of 1000
  • DEATH 76 death-typed
  • INJ 1,106 injury-typed
  • MALF 1,153 malfunction
  • SPAN 2004–2026
  • PEAK 2008: 278
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Knee, Hemi-, Femoral (34 report gap)

Stimulator, Autonomic Nerve, Implanted (Depression) sits #446 of 1000 among tracked device types with 2,349 MAUDE reports spanning 2004–2026. 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 3.2% corpus 1.5% · above corpus mean (+1.7 pp)
  • INJ 47.1% corpus 30.4% · above corpus mean (+16.6 pp)
  • MALF 49.1% corpus 64.5% · below corpus mean (-15.4 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 64% of coded problems · Lead manufacturer CYBERONICS, INC. accounts for 57% of manufacturer-tagged reports · Top event location OTHER is 52% of location-tagged rows .

Stimulator, Autonomic Nerve, Implanted 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 (Depression) carries 2,349 MAUDE reports, ranked #446 of 1000.

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

Event Types

Malfunction 1,153 (49.1%)
Injury 1,106 (47.1%)
Death 76 (3.2%)
Other 8 (0.3%)
6 (0.3%)

Patient Outcomes

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

1,071 (42.0%)
Required Intervention 477 (18.7%)
Other 406 (15.9%)
Hospitalization 192 (7.5%)
R 117 (4.6%)
Death 75 (2.9%)
Life Threatening 74 (2.9%)
Disability 55 (2.2%)
O 35 (1.4%)
L 20 (0.8%)
S 13 (0.5%)
H 11 (0.4%)
D 2 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 557
Fracture 101
High impedance 68
Insufficient Information 21
Corroded 17
Device Contamination with Body Fluid 15
Premature Discharge of Battery 14
Device Operates Differently Than Expected 12
Communication or Transmission Problem 9
Failure to Interrogate 7
Naturally Worn 7
Premature End-of-Life Indicator 7
Battery Problem 6
Mechanical Problem 6
Programming Issue 6
Computer Software Problem 5
Incomplete or Inadequate Connection 5
Device Displays Incorrect Message 4
Energy Output Problem 4
Low impedance 4

Yearly Trend

04
2004: 2
05
2005: 31
06
2006: 73
07
2007: 263
08
2008: 278
09
2009: 178
10
2010: 130
11
2011: 151
12
2012: 125
13
2013: 90
14
2014: 99
15
2015: 102
16
2016: 78
17
2017: 54
18
2018: 73
19
2019: 84
20
2020: 74
21
2021: 103
22
2022: 105
23
2023: 116
24
2024: 78
25
2025: 57
26
2026: 5

Related Entities for Stimulator, Autonomic Nerve, Implanted (Depression)

Event Locations

OTHER 1,225 (52.1%)
1,096 (46.7%)
I 15 (0.6%)
HOME 4 (0.2%)
NO INFORMATION 4 (0.2%)
HOSPITAL 3 (0.1%)
OPERATING ROOM 2 (0.1%)

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

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Stimulator, Autonomic Nerve, 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 (2,349 here).

Similar death-typed counts

Nearest other device types by death-typed report count (76 here), distinct from the volume row.

Disclaimer: MAUDE figures for Stimulator, Autonomic Nerve, 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, Autonomic Nerve, 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.