2026 data FDA MAUDE openFDA FDA Class II

Stimulator, Spinal-Cord, Implanted (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 Class II (moderate risk, special controls required), regulated under 21 CFR §882.5880 (Neurology panel).

FDA MAUDE casebook

openFDA event book Stimulator, Spinal-Cord, Implanted MID-BOOK · MAUDE

#78 of 1000 · 43,932 reports · 1993–2026

  • BOOK 43,932 reports
  • RANK #78 of 1000
  • DEATH 196 death-typed
  • INJ 41,438 injury-typed
  • MALF 1,802 malfunction
  • SPAN 1993–2026
  • PEAK 2014: 10,849
  • PHOTO Powered Laser Surgica…

Nearest event-volume peer: Powered Laser Surgical Instrument (154 report gap)

Stimulator, Spinal-Cord, Implanted (Pain Relief) sits #78 of 1000 among tracked device types with 43,932 MAUDE reports spanning 1993–2026. 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, Spinal-Cord, Implanted carries 94.3% INJURY-coded reports, 64.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
  • INJ 94.3% corpus 30.3% · above corpus mean (+64.0 pp)
  • MALF 4.1% corpus 64.8% · below corpus mean (-60.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 42% of coded problems · Lead manufacturer ST. JUDE MEDICAL - NEUROMODULATION accounts for 77% of manufacturer-tagged reports · Top event location is 49% of location-tagged rows .

Stimulator, Spinal-Cord, Implanted in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Stimulator, Spinal-Cord, Implanted (Pain Relief) carries 43,932 MAUDE reports, ranked #78 of 1000.

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

Event Types

Injury 41,438 (94.3%)
Malfunction 1,802 (4.1%)
Other 458 (1.0%)
Death 196 (0.4%)
38 (0.1%)

Patient Outcomes

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

Other 36,959 (82.7%)
Required Intervention 3,034 (6.8%)
1,863 (4.2%)
Hospitalization 1,786 (4.0%)
O 374 (0.8%)
R 297 (0.7%)
Death 216 (0.5%)
Life Threatening 38 (0.1%)
S 37 (0.1%)
H 33 (0.1%)
L 29 (0.1%)
Disability 24 (0.1%)
Congenital Anomaly 7 (0.0%)
D 2 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 20,717
Device Operates Differently Than Expected 7,609
High impedance 3,282
Impedance Problem 2,518
Temperature Problem 1,960
Communication or Transmission Problem 1,682
Use of Device Problem 1,659
Migration or Expulsion of Device 1,607
No Device Output 1,318
Fracture 1,022
Low impedance 882
Therapy Delivered to Incorrect Body Area 838
Charging Problem 784
Explanted 695
Disconnection 599
Device Inoperable 581
Insufficient Device Problem Information 517
Nonstandard Device 514
Failure to Charge 419
Unintended Movement 393

Yearly Trend

93
1993: 1
94
1994: 27
95
1995: 16
96
1996: 32
97
1997: 87
98
1998: 98
99
1999: 62
00
2000: 74
01
2001: 141
02
2002: 93
03
2003: 69
04
2004: 127
05
2005: 134
06
2006: 173
07
2007: 201
08
2008: 68
09
2009: 59
10
2010: 157
11
2011: 471
12
2012: 1,090
13
2013: 4,428
14
2014: 10,849
15
2015: 7,507
16
2016: 4,555
17
2017: 5,511
18
2018: 5,244
19
2019: 643
20
2020: 466
21
2021: 332
22
2022: 209
23
2023: 236
24
2024: 318
25
2025: 317
26
2026: 137

Reports in 2025 (317) held close to the prior two-year average of 277.

Related Entities for Stimulator, Spinal-Cord, Implanted (Pain Relief)

Event Locations

21,692 (49.4%)
I 20,546 (46.8%)
UNKNOWN 725 (1.7%)
OTHER 348 (0.8%)
HOSPITAL 339 (0.8%)
HOME 135 (0.3%)
NO INFORMATION 48 (0.1%)
INVALID DATA 43 (0.1%)
AMBULATORY SURGICAL FACILITY 38 (0.1%)
OUTPATIENT TREATMENT FACILITY 11 (0.0%)
AMBULATORY SURGICAL CENTER 2 (0.0%)
PUBLIC VENUE 2 (0.0%)
NOT APPLICABLE 1 (0.0%)
NURSING HOME 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

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

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Stimulator, Spinal-Cord, Implanted: 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 (43,932 here).

Similar death-typed counts

Nearest other device types by death-typed report count (196 here), distinct from the volume row.

Disclaimer: MAUDE figures for Stimulator, Spinal-Cord, Implanted 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, Spinal-Cord, Implanted; 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.