2026 data FDA MAUDE openFDA FDA Class III

Stimulator, Carotid Sinus Nerve

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 Class III (highest risk, premarket approval required), regulated under 21 CFR §870.3850 (Cardiovascular panel).

FDA MAUDE casebook

openFDA event book Stimulator, Carotid Sinus Nerve LIGHT-BOOK · MAUDE

#954 of 1000 · 416 reports · 2015–2026

  • BOOK 416 reports
  • RANK #954 of 1000
  • DEATH 31 death-typed
  • INJ 381 injury-typed
  • MALF 4 malfunction
  • SPAN 2015–2026
  • PEAK 2025: 137
  • PHOTO System

Nearest event-volume peer: System, Gastrointestinal Motility (Electrical) (1 report gap)

Stimulator, Carotid Sinus Nerve sits #954 of 1000 among tracked device types with 416 MAUDE reports spanning 2015–2026. 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, Carotid Sinus Nerve carries 1.0% MALFUNCTION-coded reports, 63.9pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 7.5% corpus 1.5% · above corpus mean (+5.9 pp)
  • INJ 91.6% corpus 30.3% · above corpus mean (+61.3 pp)
  • MALF 1.0% corpus 64.8% · below corpus mean (-63.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 69% of coded problems · Lead manufacturer DATASCOPE CORP. accounts for 100% of manufacturer-tagged reports · Top event location is 98% of location-tagged rows .

Stimulator, Carotid Sinus Nerve in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Stimulator, Carotid Sinus Nerve carries 416 MAUDE reports, ranked #954 of 1000.

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

Event Types

Injury 381 (91.6%)
Death 31 (7.5%)
Malfunction 4 (1.0%)

Patient Outcomes

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

Required Intervention 153 (31.5%)
Hospitalization 105 (21.6%)
Other 99 (20.4%)
H 36 (7.4%)
R 29 (6.0%)
Death 22 (4.5%)
Disability 16 (3.3%)
D 11 (2.3%)
O 8 (1.6%)
4 (0.8%)
S 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 284
Use of Device Problem 18
Material Twisted/Bent 17
Material Split, Cut or Torn 16
Unintended Movement 13
Device Dislodged or Dislocated 12
Expulsion 9
Insufficient Device Problem Information 8
High impedance 6
Low impedance 6
Appropriate Device Problem Term/Code Not Available 4
Fracture 4
Defibrillation/Stimulation Problem 2
Detachment of Device or Device Component 2
Device-Device Incompatibility 2
Improper or Incorrect Procedure or Method 2
Inappropriate/Inadequate Shock/Stimulation 2
Material Deformation 2
Material Fragmentation 2
Migration 2

Yearly Trend

15
2015: 1
16
2016: 1
17
2017: 3
18
2018: 1
19
2019: 1
21
2021: 5
22
2022: 24
23
2023: 60
24
2024: 93
25
2025: 137
26
2026: 90

Reports rose to 137 in 2025, up from an average of 77 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Stimulator, Carotid Sinus Nerve

Top Manufacturers

Event Locations

407 (97.8%)
I 9 (2.2%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Stimulator, Carotid Sinus Nerve: 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 (416 here).

Similar death-typed counts

Nearest other device types by death-typed report count (31 here), distinct from the volume row.

Disclaimer: MAUDE figures for Stimulator, Carotid Sinus Nerve 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, Carotid Sinus Nerve; 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.