2026 data FDA MAUDE openFDA

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 · 362,034 reports · 1992–2026

  • BOOK 362,034 reports
  • RANK #11 of 1000
  • DEATH 1,806 death-typed
  • INJ 259,356 injury-typed
  • MALF 100,277 malfunction
  • SPAN 1992–2026
  • PEAK 2024: 35,077
  • PHOTO Implantable Cardiover…

Nearest event-volume peer: Implantable Cardioverter Defibrillator (Non-Crt) (7,278 report gap)

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief sits #11 of 1000 among tracked device types with 362,034 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 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 71.6% corpus 30.4% · above corpus mean (+41.2 pp)
  • MALF 27.7% corpus 64.5% · below corpus mean (-36.8 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 22% of manufacturer-tagged reports · Top event location is 56% 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 362,034 MAUDE reports, ranked #11 of 1000.

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

Event Types

Injury 259,356 (71.6%)
Malfunction 100,277 (27.7%)
Death 1,806 (0.5%)
Other 533 (0.1%)
62 (0.0%)

Patient Outcomes

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

Required Intervention 140,284 (37.8%)
Other 116,383 (31.4%)
93,950 (25.3%)
Hospitalization 8,575 (2.3%)
R 5,905 (1.6%)
Death 1,831 (0.5%)
O 1,585 (0.4%)
H 1,395 (0.4%)
S 412 (0.1%)
Life Threatening 278 (0.1%)
Disability 269 (0.1%)
L 219 (0.1%)
Congenital Anomaly 46 (0.0%)
D 43 (0.0%)
C 2 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 65,005
Charging Problem 35,566
High impedance 27,719
Battery Problem 26,435
Insufficient Information 20,525
Migration 19,924
Unexpected Therapeutic Results 14,441
Communication or Transmission Problem 12,408
Therapeutic or Diagnostic Output Failure 12,244
Wireless Communication Problem 11,997
Failure to Deliver Energy 11,977
Overheating of Device 11,758
Migration or Expulsion of Device 10,023
Device Operates Differently Than Expected 9,348
Improper or Incorrect Procedure or Method 8,422
Inappropriate/Inadequate Shock/Stimulation 8,312
Failure to Interrogate 6,957
Energy Output Problem 6,686
Delayed Charge Time 5,794
Connection Problem 5,662

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: 432
07
2007: 1,094
08
2008: 3,018
09
2009: 5,251
10
2010: 9,262
11
2011: 11,133
12
2012: 17,914
13
2013: 22,432
14
2014: 11,250
15
2015: 11,690
16
2016: 15,644
17
2017: 18,612
18
2018: 23,626
19
2019: 30,037
20
2020: 28,106
21
2021: 24,333
22
2022: 23,271
23
2023: 33,528
24
2024: 35,077
25
2025: 31,445
26
2026: 4,383

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

Event Locations

202,373 (55.9%)
I 142,104 (39.3%)
OTHER 13,155 (3.6%)
HOSPITAL 2,386 (0.7%)
HOME 866 (0.2%)
UNKNOWN 606 (0.2%)
NO INFORMATION 374 (0.1%)
AMBULATORY SURGICAL FACILITY 115 (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 BOSTON SCIENTIFIC NEUROMODULATION →

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.

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.