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2026 data FDA MAUDE openFDA FDA Class III

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.

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FDA MAUDE casebook

openFDA event book Stimulator, Autonomic Nerve, Implanted LIGHT-BOOK · MAUDE

#460 of 1000 · 2,367 reports · 2004–2026

  • BOOK 2,367 reports
  • RANK #460 of 1000
  • DEATH 77 death-typed
  • INJ 1,117 injury-typed
  • MALF 1,159 malfunction
  • SPAN 2004–2026
  • PEAK 2008: 278
  • PHOTO Electrode

Nearest event-volume peer: Electrode, Electrosurgical, Active, Urological (5 report gap)

Stimulator, Autonomic Nerve, Implanted (Depression) sits #460 of 1000 among tracked device types with 2,367 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 →

Injury-coded reports run above the device-type norm

Stimulator, Autonomic Nerve, Implanted carries 47.2% INJURY-coded reports, 16.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.3% corpus 1.5% · above corpus mean (+1.7 pp)
  • INJ 47.2% corpus 30.3% · above corpus mean (+16.9 pp)
  • MALF 49.0% corpus 64.8% · below corpus mean (-15.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 28% 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 2,367 MAUDE reports, ranked #460 of 1000.

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

Event Types

Malfunction 1,159 (49.0%)
Injury 1,117 (47.2%)
Death 77 (3.3%)
Other 8 (0.3%)
6 (0.3%)

Patient Outcomes

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

1,072 (41.9%)
Required Intervention 478 (18.7%)
Other 411 (16.1%)
Hospitalization 193 (7.5%)
R 117 (4.6%)
Death 76 (3.0%)
Life Threatening 75 (2.9%)
Disability 55 (2.1%)
O 35 (1.4%)
L 20 (0.8%)
S 13 (0.5%)
H 12 (0.5%)
D 2 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 657
High impedance 294
Insufficient Device Problem Information 264
Device remains implanted 253
Fracture 118
Unknown (for use when the device problem is not known) 86
Explanted 83
Device Operates Differently Than Expected 81
Failure to Interrogate 68
Use of Incorrect Control/Treatment Settings 64
Replace 56
No Display/Image 51
Battery Problem 42
Repair 37
Device Displays Incorrect Message 36
Programming Issue 35
Communication or Transmission Problem 34
Migration or Expulsion of Device 33
Failure of Device to Self-Test 24
Device Inoperable 23

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: 23

Reports fell to 57 in 2025, down from an average of 97 in the two years before.

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

Top Manufacturers

CYBERONICS, INC. 1,294
LIVANOVA USA, INC. 521
CYBERONICS - HOUSTON 244
CYBERONICS INC 181
CYBERONICS INC. 26
CYBERONICS, INC 3

Event Locations

OTHER 1,225 (51.8%)
1,114 (47.1%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Stimulator, Autonomic Nerve, Implanted: 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 (2,367 here).

Electrode 2,372 Intervertebral Fusion Device With Integrate… 2,375 Catheter, Peritoneal, Long-Term Indwelling 2,355 Circuit, Breathing 2,347

Similar death-typed counts

Nearest other device types by death-typed report count (77 here), distinct from the volume row.

Catheter, Ultrasound, Intravascular 77 Pulmonary Valve Prosthesis Percutaneously D… 77 Stylet, Catheter 77 Tricuspid Valve Repair Device 77

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

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.