2026 data FDA MAUDE openFDA FDA Class III

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

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 HEAVY-BOOK · MAUDE

#11 of 1000 · 375,710 reports · 1992–2026

  • BOOK 375,710 reports
  • RANK #11 of 1000
  • DEATH 1,904 death-typed
  • INJ 270,266 injury-typed
  • MALF 102,938 malfunction
  • SPAN 1992–2026
  • PEAK 2024: 35,076
  • PHOTO Implantable Cardiover…

Nearest event-volume peer: Implantable Cardioverter Defibrillator (Non-Crt) (3,643 report gap)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief sits #11 of 1000 among tracked device types with 375,710 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 71.9% INJURY-coded reports, 41.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 71.9% corpus 30.3% · above corpus mean (+41.6 pp)
  • MALF 27.4% corpus 64.8% · below corpus mean (-37.4 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 19% of coded problems · Lead manufacturer MEDTRONIC PUERTO RICO OPERATIONS CO. accounts for 22% of manufacturer-tagged reports · Top event location is 57% 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, Spinal-Cord, Totally Implanted For Pain Relief carries 375,710 MAUDE reports, ranked #11 of 1000.

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

Event Types

Injury 270,266 (71.9%)
Malfunction 102,938 (27.4%)
Death 1,904 (0.5%)
Other 540 (0.1%)
62 (0.0%)

Patient Outcomes

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

Required Intervention 144,816 (37.7%)
Other 121,473 (31.6%)
96,685 (25.2%)
Hospitalization 8,861 (2.3%)
R 6,098 (1.6%)
Death 1,894 (0.5%)
O 1,645 (0.4%)
H 1,597 (0.4%)
S 428 (0.1%)
Life Threatening 291 (0.1%)
Disability 287 (0.1%)
L 234 (0.1%)
D 46 (0.0%)
Congenital Anomaly 46 (0.0%)
C 2 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 78,928
Charging Problem 42,135
High impedance 36,284
Battery Problem 29,216
Device Operates Differently Than Expected 28,409
Insufficient Device Problem Information 25,625
Migration 21,284
Communication or Transmission Problem 18,769
Migration or Expulsion of Device 17,643
Failure to Deliver Energy 16,489
Unexpected Therapeutic Results 16,038
Inappropriate/Inadequate Shock/Stimulation 13,795
Therapeutic or Diagnostic Output Failure 13,099
Overheating of Device 12,968
Wireless Communication Problem 12,708
Improper or Incorrect Procedure or Method 9,835
Failure to Interrogate 8,428
No Apparent Adverse Event 7,841
Impedance Problem 7,284
Energy Output Problem 7,263

Yearly Trend

92
1992: 1
00
2000: 5
01
2001: 18
02
2002: 23
03
2003: 33
04
2004: 152
05
2005: 264
06
2006: 433
07
2007: 1,095
08
2008: 3,018
09
2009: 5,251
10
2010: 9,262
11
2011: 11,132
12
2012: 17,913
13
2013: 22,433
14
2014: 11,250
15
2015: 11,690
16
2016: 15,644
17
2017: 18,612
18
2018: 23,626
19
2019: 30,038
20
2020: 28,106
21
2021: 24,333
22
2022: 23,271
23
2023: 33,527
24
2024: 35,076
25
2025: 31,445
26
2026: 18,059

Reports in 2025 (31,445) held close to the prior two-year average of 34,302.

Related Entities for Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Event Locations

216,005 (57.5%)
I 142,036 (37.8%)
OTHER 13,155 (3.5%)
HOSPITAL 2,497 (0.7%)
HOME 866 (0.2%)
UNKNOWN 606 (0.2%)
NO INFORMATION 374 (0.1%)
AMBULATORY SURGICAL FACILITY 116 (0.0%)
OUTPATIENT TREATMENT FACILITY 33 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 9 (0.0%)
NURSING HOME 6 (0.0%)
INVALID DATA 4 (0.0%)
N 1 (0.0%)
NOT APPLICABLE 1 (0.0%)
OPERATING ROOM 1 (0.0%)

Compare MEDTRONIC PUERTO RICO OPERATIONS CO. vs ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) →

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.

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.