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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.

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FDA MAUDE casebook

openFDA event book Intestinal Stimulator LIGHT-BOOK · MAUDE

#337 of 1000 · 4,295 reports · 2002–2026

  • BOOK 4,295 reports
  • RANK #337 of 1000
  • DEATH 72 death-typed
  • INJ 2,863 injury-typed
  • MALF 1,334 malfunction
  • SPAN 2002–2026
  • PEAK 2017: 438
  • PHOTO Stimulator

Nearest event-volume peer: Stimulator, Peripheral Nerve, Implanted (Pain Relief) (0 report gap)

Intestinal Stimulator sits #337 of 1000 among tracked device types with 4,295 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 →

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 1.7% corpus 1.5% · near corpus mean (+0.2 pp)
  • INJ 66.7% corpus 30.4% · above corpus mean (+36.2 pp)
  • MALF 31.1% corpus 64.5% · below corpus mean (-33.4 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 45% 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 4,295 MAUDE reports, ranked #337 of 1000.

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

Event Types

Injury 2,863 (66.7%)
Malfunction 1,334 (31.1%)
Death 72 (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 1,664 (34.5%)
1,198 (24.8%)
Hospitalization 743 (15.4%)
Other 497 (10.3%)
R 413 (8.6%)
Life Threatening 110 (2.3%)
Death 74 (1.5%)
L 51 (1.1%)
O 39 (0.8%)
S 17 (0.4%)
H 16 (0.3%)
Disability 7 (0.1%)
D 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 620
Insufficient Information 414
Device Operates Differently Than Expected 361
Inappropriate/Inadequate Shock/Stimulation 327
Migration or Expulsion of Device 219
High impedance 186
Battery Problem 136
Electromagnetic Compatibility Problem 117
Break 107
Premature Discharge of Battery 89
Impedance Problem 83
Failure to Deliver Energy 75
Unstable 74
Patient Device Interaction Problem 60
Low Battery 59
Electromagnetic Interference 53
Energy Output Problem 53
Unintended Collision 53
Malposition of Device 48
Intermittent Continuity 32

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: 29

Related Entities for Intestinal Stimulator

Top Manufacturers

MEDTRONIC PUERTO RICO OPERATIONS CO. 1,504
MEDTRONIC MED REL MEDTRONIC PUERTO RICO 1,103
MEDTRONIC NEUROMODULATION 779
MDT PUERTO RICO OPERATIONS CO., JUNCOS 195
MDT PUERTO RICO OPERATIONS CO 84
MDT SOFAMOR DANEK PUERTO RICO MFG 51

Event Locations

I 1,912 (44.5%)
1,801 (41.9%)
OTHER 525 (12.2%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Intestinal Stimulator, 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 (4,295 here).

Stimulator, Peripheral Nerve, Implanted 4,295 Implant, Eye Valve 4,290 System, Hypothermia, Intravenous, Cooling 4,279 Pack, Hot Or Cold, Disposable 4,263

Similar death-typed counts

Nearest other device types by death-typed report count (72 here), distinct from the volume row.

Catheter, Hemodialysis, Non-Implanted 72 Catheter, Ultrasound, Intravascular 72 Prosthesis 72 Ligator, Esophageal 71

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

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.