2026 data FDA MAUDE openFDA FDA Class III

Stimulator, Hypoglossal Nerve, Implanted, Apnea

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 LIGHT-BOOK · MAUDE

#373 of 1000 · 3,486 reports · 2014–2026

  • BOOK 3,486 reports
  • RANK #373 of 1000
  • DEATH 4 death-typed
  • INJ 3,320 injury-typed
  • MALF 161 malfunction
  • SPAN 2014–2026
  • PEAK 2025: 960
  • PHOTO Extractor

Nearest event-volume peer: Extractor (1 report gap)

Stimulator, Hypoglossal Nerve, Implanted, Apnea sits #373 of 1000 among tracked device types with 3,486 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 → · Similar-volume device →

Injury-coded reports run above the device-type norm

Stimulator carries 95.2% INJURY-coded reports, 64.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 95.2% corpus 30.3% · above corpus mean (+64.9 pp)
  • MALF 4.6% corpus 64.8% · below corpus mean (-60.2 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 79% of coded problems · Top event location is 88% 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, Hypoglossal Nerve, Implanted, Apnea carries 3,486 MAUDE reports, ranked #373 of 1000.

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

Event Types

Injury 3,320 (95.2%)
Malfunction 161 (4.6%)
Death 4 (0.1%)
Other 1 (0.0%)

Patient Outcomes

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

Required Intervention 2,744 (68.8%)
Other 447 (11.2%)
R 416 (10.4%)
O 120 (3.0%)
92 (2.3%)
Hospitalization 65 (1.6%)
H 41 (1.0%)
Disability 17 (0.4%)
S 16 (0.4%)
Life Threatening 13 (0.3%)
L 9 (0.2%)
Death 6 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 2,690
Migration 195
Migration or Expulsion of Device 166
Device Sensing Problem 115
Expulsion 41
Malposition of Device 35
Insufficient Device Problem Information 17
Detachment of Device or Device Component 16
Inappropriate/Inadequate Shock/Stimulation 16
Appropriate Device Problem Term/Code Not Available 15
Failure to Deliver Energy 14
Patient Device Interaction Problem 14
Therapeutic or Diagnostic Output Failure 14
Improper or Incorrect Procedure or Method 11
Material Twisted/Bent 11
Device Dislodged or Dislocated 9
Positioning Problem 9
Defective Device 8
Material Split, Cut or Torn 8
Impedance Problem 7

Yearly Trend

14
2014: 1
15
2015: 3
16
2016: 11
17
2017: 22
18
2018: 55
19
2019: 92
20
2020: 79
21
2021: 218
22
2022: 283
23
2023: 460
24
2024: 697
25
2025: 960
26
2026: 605

Reports rose to 960 in 2025, up from an average of 579 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Stimulator, Hypoglossal Nerve, Implanted, Apnea

Event Locations

3,055 (87.6%)
I 395 (11.3%)
HOSPITAL 18 (0.5%)
NO INFORMATION 14 (0.4%)
HOME 1 (0.0%)
OTHER 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

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 (3,486 here).

Similar death-typed counts

Nearest other device types by death-typed report count (4 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.