2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Stimulator MID-BOOK · MAUDE

#44 of 1000 · 79,738 reports · 1992–2026

  • BOOK 79,738 reports
  • RANK #44 of 1000
  • DEATH 80 death-typed
  • INJ 38,635 injury-typed
  • MALF 40,807 malfunction
  • SPAN 1992–2026
  • PEAK 2017: 8,097
  • PHOTO Laparoscope

Nearest event-volume peer: Laparoscope, General & Plastic Surgery (592 report gap)

Stimulator, Electrical, Implantable, For Incontinence sits #44 of 1000 among tracked device types with 79,738 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 →

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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 48.5% corpus 30.4% · above corpus mean (+18.0 pp)
  • MALF 51.2% corpus 64.5% · below corpus mean (-13.3 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 15% of coded problems · Lead manufacturer MEDTRONIC PUERTO RICO OPERATIONS CO. accounts for 56% of manufacturer-tagged reports · Top event location is 47% 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 79,738 MAUDE reports, ranked #44 of 1000.

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

Event Types

Malfunction 40,807 (51.2%)
Injury 38,635 (48.5%)
Other 201 (0.3%)
Death 80 (0.1%)
15 (0.0%)

Patient Outcomes

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

40,387 (48.9%)
Required Intervention 30,120 (36.4%)
Other 6,534 (7.9%)
Hospitalization 2,280 (2.8%)
R 2,026 (2.5%)
O 449 (0.5%)
H 411 (0.5%)
Life Threatening 128 (0.2%)
S 77 (0.1%)
Disability 77 (0.1%)
Death 76 (0.1%)
L 67 (0.1%)
Congenital Anomaly 11 (0.0%)
D 2 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 13,008
Insufficient Information 9,844
Failure to Deliver Energy 8,013
Device Operates Differently Than Expected 7,894
Migration or Expulsion of Device 7,553
Inappropriate/Inadequate Shock/Stimulation 5,056
Unintended Collision 4,197
Energy Output Problem 3,942
Communication or Transmission Problem 3,866
Break 3,562
Battery Problem 3,492
Electromagnetic Compatibility Problem 2,994
Therapy Delivered to Incorrect Body Area 2,815
Failure to Interrogate 2,603
High impedance 2,517
Electromagnetic Interference 2,187
Malposition of Device 1,786
Device Displays Incorrect Message 1,537
Intermittent Continuity 1,353
Patient Device Interaction Problem 1,347

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: 979

Related Entities for Stimulator, Electrical, Implantable, For Incontinence

Event Locations

37,789 (47.4%)
I 37,117 (46.5%)
OTHER 4,499 (5.6%)
NO INFORMATION 161 (0.2%)
HOSPITAL 81 (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 similar MAUDE profiles

Two openFDA-derived peer sets for 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 (79,738 here).

Similar death-typed counts

Nearest other device types by death-typed report count (80 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.