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2026 data FDA MAUDE openFDA FDA Class II

Stimulator, Peripheral Nerve, 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 §882.5870 (Neurology panel).

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FDA MAUDE casebook

openFDA event book Stimulator, Peripheral Nerve, Implanted LIGHT-BOOK · MAUDE

#339 of 1000 · 4,474 reports · 1999–2026

  • BOOK 4,474 reports
  • RANK #339 of 1000
  • DEATH 16 death-typed
  • INJ 4,382 injury-typed
  • MALF 71 malfunction
  • SPAN 1999–2026
  • PEAK 2024: 678
  • PHOTO Computer

Nearest event-volume peer: Computer, Diagnostic, Programmable (33 report gap)

Stimulator, Peripheral Nerve, Implanted (Pain Relief) sits #339 of 1000 among tracked device types with 4,474 MAUDE reports spanning 1999–2026. 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, Peripheral Nerve, Implanted carries 97.9% INJURY-coded reports, 67.7pp 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 97.9% corpus 30.3% · above corpus mean (+67.7 pp)
  • MALF 1.6% corpus 64.8% · below corpus mean (-63.2 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 55% of coded problems · Lead manufacturer ST. JUDE MEDICAL - NEUROMODULATION accounts for 91% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .

Stimulator, Peripheral Nerve, Implanted in the event-volume neighbourhood

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

reports

What this shows Stimulator, Peripheral Nerve, Implanted (Pain Relief) carries 4,474 MAUDE reports, ranked #339 of 1000.

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

Event Types

Injury 4,382 (97.9%)
Malfunction 71 (1.6%)
Death 16 (0.4%)
Other 3 (0.1%)
2 (0.0%)

Patient Outcomes

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

Other 2,904 (64.9%)
Required Intervention 960 (21.4%)
464 (10.4%)
Hospitalization 71 (1.6%)
R 25 (0.6%)
Death 16 (0.4%)
O 15 (0.3%)
H 9 (0.2%)
Congenital Anomaly 4 (0.1%)
S 3 (0.1%)
Disability 3 (0.1%)
L 2 (0.0%)
Life Threatening 2 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 2,468
Use of Device Problem 343
Migration 309
Device Operates Differently Than Expected 291
Impedance Problem 155
Insufficient Device Problem Information 150
High impedance 140
Intermittent Communication Failure 115
Migration or Expulsion of Device 115
Fracture 89
Device Unsafe to Use in Environment 48
Appropriate Device Problem Term/Code Not Available 46
Malposition of Device 41
Off-Label Use 40
Improper or Incorrect Procedure or Method 39
Expulsion 33
Lack of Effect 28
Inappropriate/Inadequate Shock/Stimulation 25
Material Erosion 25
Therapy Delivered to Incorrect Body Area 18

Yearly Trend

99
1999: 2
01
2001: 1
04
2004: 1
07
2007: 7
08
2008: 13
09
2009: 10
10
2010: 24
11
2011: 17
12
2012: 12
13
2013: 77
14
2014: 268
15
2015: 346
16
2016: 414
17
2017: 330
18
2018: 318
19
2019: 64
20
2020: 104
21
2021: 226
22
2022: 183
23
2023: 524
24
2024: 678
25
2025: 602
26
2026: 253

Reports in 2025 (602) held close to the prior two-year average of 601.

Related Entities for Stimulator, Peripheral Nerve, Implanted (Pain Relief)

Top Manufacturers

ST. JUDE MEDICAL - NEUROMODULATION 1,640
MEDTRONIC NEUROMODULATION 94
ST JUDE MEDICAL - NEUROMODULATION 36
ST. JUDE MEDICAL ¿ NEUROMODULATION 24
ST. JUDE MEDICAL- NEUROMODULATION 11

Event Locations

2,800 (62.6%)
I 1,581 (35.3%)
OTHER 62 (1.4%)
HOME 15 (0.3%)
NO INFORMATION 6 (0.1%)
UNKNOWN 6 (0.1%)
HOSPITAL 3 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)

Compare ST. JUDE MEDICAL - NEUROMODULATION vs MEDTRONIC NEUROMODULATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Stimulator, Peripheral Nerve, 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 (4,474 here).

Computer, Diagnostic, Programmable 4,441 Fluorometer, For Clinical Use 4,519 Vaporizer, Anesthesia, Non-Heated 4,534 Pack, Hot Or Cold, Disposable 4,404

Similar death-typed counts

Nearest other device types by death-typed report count (16 here), distinct from the volume row.

Catheter And Tip, Suction 16 Computer 16 Dilator, Esophageal 16 Implanted Subcortical Electrical Stimulator 16

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

Disclaimer: MAUDE figures for Stimulator, Peripheral Nerve, 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, Peripheral Nerve, 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.