OctrodeRecalls & reported problems across all models
St. Jude Medical, Inc. · 10 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 36,740
- Deaths reported
- 68
- Injuries reported
- 36,583
- Recalls
- 0
We found 10 models of Octrode by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 36,740 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Sep 30, 2026 — classified as 68 deaths, 36,583 injuries, 88 malfunctions.
The most frequently reported specific device problem is “Migration” (10,756 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Octrode problems
Device problems
- Migration10,756
- High impedance9,784
- Adverse Event Without Identified Device or Use Problem7,142
- Therapeutic or Diagnostic Output Failure5,027
- Fracture2,640
- Impedance Problem1,072
- Low impedance551
- Patient-Device Incompatibility393
Patient problems
- Inadequate Pain Relief27,278
- No Clinical Signs, Symptoms or Conditions3,010
- Failure of Implant2,399
- No Consequences Or Impact To Patient1,156
- Undesired Nerve Stimulation928
- Post Operative Wound Infection913
- Cerebrospinal Fluid Leakage652
- Unspecified Infection638
Octrode models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Octrode™ 3186STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF30 deaths32,096 reports
- Octrode™ 3189STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF8 deaths2,238 reports
- Octrode™ 3086STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)30 deaths1,538 reports
- Octrode™ 3186STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF536 reports
- Octrode™ 3189Stimulator, spinal-cord, totally implanted for pain relief197 reports
- Octrode™ 3189STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF68 reports
- Octrode™ 3183STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF39 reports
- Octrode™ 3189STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF13 reports
- Octrode™ 3183STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF12 reports
- Octrode™ 3086STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)3 reports
Recent Octrode adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026High impedance
Patient problems: Inadequate Pain Relief
MAUDE report 50955028 ↗InjurySep 30, 2026High impedance
Patient problems: Inadequate Pain Relief
MAUDE report 50955026 ↗InjurySep 30, 2026High impedance
Patient problems: Inadequate Pain Relief
MAUDE report 50954525 ↗InjurySep 30, 2026Migration
Patient problems: Inadequate Pain Relief
MAUDE report 50953852 ↗InjurySep 30, 2026Migration
Patient problems: Inadequate Pain Relief
MAUDE report 50953840 ↗InjurySep 30, 2026Therapeutic or Diagnostic Output Failure
Patient problems: Inadequate Pain Relief
MAUDE report 50949226 ↗InjurySep 30, 2026High impedance
Patient problems: Inadequate Pain Relief
MAUDE report 50947567 ↗InjurySep 30, 2026Migration
It was reported that the patient lead had migrated and was confirmed with imaging. As a result, surgical intervention was undertaken wherein the lead was explanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946025 ↗InjurySep 29, 2026Therapeutic or Diagnostic Output Failure
Patient problems: Inadequate Pain Relief
MAUDE report 50941202 ↗InjurySep 29, 2026Inappropriate/Inadequate Shock/Stimulation
Patient problems: Undesired Nerve Stimulation
MAUDE report 50941201 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Gastrointestinal Problem
MAUDE report 50941199 ↗InjurySep 29, 2026Therapeutic or Diagnostic Output Failure
Patient problems: Inadequate Pain Relief
MAUDE report 50940954 ↗InjurySep 29, 2026High impedance
Patient problems: Inadequate Pain Relief
MAUDE report 50939588 ↗InjurySep 29, 2026High impedance
Patient problems: Inadequate Pain Relief
MAUDE report 50939583 ↗InjurySep 29, 2026High impedance
Patient problems: Inadequate Pain Relief
MAUDE report 50939149 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Proclaim12 models · 35,038 reports · 17 recalls
- Durata28 models · 19,805 reports
- Assurity MRI2 models · 17,838 reports · 1 recall
- Gallant8 models · 12,885 reports · 5 recalls
- Quartet10 models · 11,001 reports
- MitraClip19 models · 9,056 reports · 2 recalls
- Fortify Assura8 models · 8,292 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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