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2026 data FDA MAUDE openFDA FDA Class III

Stimulator, Electrical, Implantable, For Incontinence

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 §876.5270 (Gastroenterology, Urology panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Stimulator MID-BOOK · MAUDE

#45 of 1000 · 82,555 reports · 1992–2026

  • BOOK 82,555 reports
  • RANK #45 of 1000
  • DEATH 80 death-typed
  • INJ 40,196 injury-typed
  • MALF 42,062 malfunction
  • SPAN 1992–2026
  • PEAK 2017: 8,097
  • PHOTO Laparoscope

Nearest event-volume peer: Laparoscope, General & Plastic Surgery (859 report gap)

Stimulator, Electrical, Implantable, For Incontinence sits #45 of 1000 among tracked device types with 82,555 MAUDE reports spanning 1992–2026. 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 carries 48.7% INJURY-coded reports, 18.4pp 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 48.7% corpus 30.3% · above corpus mean (+18.4 pp)
  • MALF 51.0% corpus 64.8% · below corpus mean (-13.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 14% of coded problems · Lead manufacturer MEDTRONIC PUERTO RICO OPERATIONS CO. accounts for 56% of manufacturer-tagged reports · Top event location is 49% 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, Electrical, Implantable, For Incontinence carries 82,555 MAUDE reports, ranked #45 of 1000.

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

Event Types

Malfunction 42,062 (51.0%)
Injury 40,196 (48.7%)
Other 202 (0.2%)
Death 80 (0.1%)
15 (0.0%)

Patient Outcomes

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

41,408 (48.8%)
Required Intervention 30,894 (36.4%)
Other 6,647 (7.8%)
Hospitalization 2,380 (2.8%)
R 2,120 (2.5%)
H 511 (0.6%)
O 482 (0.6%)
Life Threatening 130 (0.2%)
Disability 81 (0.1%)
S 77 (0.1%)
Death 76 (0.1%)
L 68 (0.1%)
Congenital Anomaly 11 (0.0%)
D 2 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 16,824
Device Operates Differently Than Expected 14,920
Insufficient Device Problem Information 11,395
Failure to Deliver Energy 10,722
Migration or Expulsion of Device 9,484
Inappropriate/Inadequate Shock/Stimulation 7,718
Unintended Collision 5,251
Communication or Transmission Problem 4,796
Break 4,723
High impedance 4,221
Energy Output Problem 4,206
Electromagnetic Compatibility Problem 3,929
Battery Problem 3,918
Therapy Delivered to Incorrect Body Area 3,725
Electromagnetic Interference 3,274
Failure to Interrogate 3,094
Device Displays Incorrect Message 2,698
Malposition of Device 2,195
Intermittent Continuity 2,095
Patient Device Interaction Problem 1,455

Yearly Trend

92
1992: 1
96
1996: 1
99
1999: 1
00
2000: 1
01
2001: 10
02
2002: 5
03
2003: 16
04
2004: 57
05
2005: 62
06
2006: 59
07
2007: 168
08
2008: 724
09
2009: 1,010
10
2010: 1,424
11
2011: 1,610
12
2012: 2,815
13
2013: 3,736
14
2014: 4,603
15
2015: 5,977
16
2016: 7,083
17
2017: 8,097
18
2018: 5,737
19
2019: 4,772
20
2020: 4,118
21
2021: 4,479
22
2022: 4,318
23
2023: 5,056
24
2024: 5,773
25
2025: 7,046
26
2026: 3,796

Reports in 2025 (7,046) held close to the prior two-year average of 5,415.

Related Entities for Stimulator, Electrical, Implantable, For Incontinence

Top Manufacturers

MEDTRONIC PUERTO RICO OPERATIONS CO. 43,633
MEDTRONIC MED REL MEDTRONIC PUERTO RICO 16,485
MEDTRONIC NEUROMODULATION 13,798
MDT PUERTO RICO OPERATIONS CO., JUNCOS 1,824
MDT PUERTO RICO OPERATIONS CO 1,054
MPRI 483

Event Locations

40,611 (49.2%)
I 37,110 (45.0%)
OTHER 4,499 (5.4%)
NO INFORMATION 161 (0.2%)
HOSPITAL 83 (0.1%)
UNKNOWN 43 (0.1%)
NOT APPLICABLE 35 (0.0%)
HOME 9 (0.0%)
AMBULATORY SURGICAL FACILITY 4 (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 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 (82,555 here).

Laparoscope, General & Plastic Surgery 83,414 Orthopedic Manual Surgical Instrument 81,214 Intraocular Lens 79,358 Analyzer, Chemistry, For Clinical Use 78,872

Similar death-typed counts

Nearest other device types by death-typed report count (80 here), distinct from the volume row.

Monitor, Bed Patient 80 Percutaneously Delivered Prostheses And Tri… 80 Unit, Liquid-Oxygen, Portable 80 Instrument, Ultrasonic Surgical 81

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

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.