2026 data FDA MAUDE openFDA

Intestinal Stimulator

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 Intestinal Stimulator LIGHT-BOOK · MAUDE

#344 of 1000 · 4,382 reports · 2002–2026

  • BOOK 4,382 reports
  • RANK #344 of 1000
  • DEATH 74 death-typed
  • INJ 2,937 injury-typed
  • MALF 1,345 malfunction
  • SPAN 2002–2026
  • PEAK 2017: 438
  • PHOTO Implant, Eye Valve

Nearest event-volume peer: Implant, Eye Valve (3 report gap)

Intestinal Stimulator sits #344 of 1000 among tracked device types with 4,382 MAUDE reports spanning 2002–2026. 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

Intestinal Stimulator carries 67.0% INJURY-coded reports, 36.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.7% corpus 1.5% · near corpus mean (+0.2 pp)
  • INJ 67.0% corpus 30.3% · above corpus mean (+36.7 pp)
  • MALF 30.7% corpus 64.8% · below corpus mean (-34.1 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 20% of coded problems · Lead manufacturer MEDTRONIC PUERTO RICO OPERATIONS CO. accounts for 40% of manufacturer-tagged reports · Top event location I is 44% of location-tagged rows .

Intestinal Stimulator in the event-volume neighbourhood

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

reports

What this shows Intestinal Stimulator carries 4,382 MAUDE reports, ranked #344 of 1000.

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

Event Types

Injury 2,937 (67.0%)
Malfunction 1,345 (30.7%)
Death 74 (1.7%)
Other 26 (0.6%)

Patient Outcomes

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

Required Intervention 1,665 (33.9%)
1,215 (24.7%)
Hospitalization 744 (15.1%)
Other 563 (11.5%)
R 413 (8.4%)
Life Threatening 110 (2.2%)
Death 75 (1.5%)
L 51 (1.0%)
O 39 (0.8%)
S 17 (0.3%)
H 16 (0.3%)
Disability 7 (0.1%)
D 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 1,025
Device Operates Differently Than Expected 735
Inappropriate/Inadequate Shock/Stimulation 579
Insufficient Device Problem Information 531
Migration or Expulsion of Device 340
High impedance 279
Battery Problem 181
Break 169
Electromagnetic Compatibility Problem 163
Premature Discharge of Battery 142
Electromagnetic Interference 126
Failure to Deliver Energy 109
Impedance Problem 104
Low Battery 101
Unstable 98
Malposition of Device 85
Unintended Collision 75
Explanted 74
Patient Device Interaction Problem 60
Energy Output Problem 55

Yearly Trend

02
2002: 2
03
2003: 1
04
2004: 8
05
2005: 7
06
2006: 8
07
2007: 23
08
2008: 141
09
2009: 109
10
2010: 149
11
2011: 157
12
2012: 232
13
2013: 261
14
2014: 413
15
2015: 300
16
2016: 377
17
2017: 438
18
2018: 325
19
2019: 258
20
2020: 177
21
2021: 188
22
2022: 185
23
2023: 165
24
2024: 160
25
2025: 182
26
2026: 116

Reports in 2025 (182) held close to the prior two-year average of 163.

Related Entities for Intestinal Stimulator

Event Locations

I 1,912 (43.6%)
1,888 (43.1%)
OTHER 525 (12.0%)
NO INFORMATION 38 (0.9%)
HOSPITAL 7 (0.2%)
NOT APPLICABLE 7 (0.2%)
UNKNOWN 4 (0.1%)
INVALID DATA 1 (0.0%)

Compare MEDTRONIC PUERTO RICO OPERATIONS CO. vs MEDTRONIC MED REL MEDTRONIC PUERTO RICO →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Intestinal 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 (4,382 here).

Similar death-typed counts

Nearest other device types by death-typed report count (74 here), distinct from the volume row.

Disclaimer: MAUDE figures for Intestinal 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 Intestinal 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.