OctrodeRecalls & reported problems across all models
Advanced Neuromodulation Systems, Inc. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,507
- Deaths reported
- 2
- Injuries reported
- 1,498
- Recalls
- 0
We found 2 models of Octrode by Advanced Neuromodulation Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 1,507 adverse event reports in the FDA's MAUDE database, received between Jun 14, 2018 and Sep 30, 2026 — classified as 2 deaths, 1,498 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (420 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
- Therapeutic or Diagnostic Output Failure420
- High impedance343
- Migration254
- Adverse Event Without Identified Device or Use Problem164
- Insufficient Device Problem Information121
- Fracture101
- Impedance Problem42
- Inappropriate/Inadequate Shock/Stimulation35
Patient problems
- Inadequate Pain Relief1,109
- No Clinical Signs, Symptoms or Conditions116
- No Consequences Or Impact To Patient75
- Failure of Implant48
- Undesired Nerve Stimulation46
- No Known Impact Or Consequence To Patient43
- Insufficient Information38
- Unspecified Infection21
Octrode models
2 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 RELIEF2 deaths1,455 reports
- Octrode® 3183STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF52 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, 2026Migration
Patient problems: Inadequate Pain Relief
MAUDE report 50949691 ↗InjurySep 30, 2026Migration
Patient problems: Inadequate Pain Relief
MAUDE report 50949687 ↗InjurySep 29, 2026Material Fragmentation
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 50936380 ↗InjurySep 24, 2026Insufficient Device Problem Information
It was reported that the patient had their lead explanted on an unknown date for an unknown reason.
Patient problems: Insufficient Information
MAUDE report 50883934 ↗InjurySep 23, 2026Therapeutic or Diagnostic Output Failure
It was reported that one of the patient's leads exhibited high impedances. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the lead was explanted and replaced to address the issue. Effective therapy was restored post operatively. It is unknown which lead was impeded.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870989 ↗InjurySep 23, 2026High impedance
It was reported that the patient¿s therapy strength was decreasing on its own. Impedance check revealed high impedances. As such, surgical intervention may take place at a later date to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50863539 ↗InjurySep 16, 2026Therapeutic or Diagnostic Output Failure
Patient problems: Inadequate Pain Relief
MAUDE report 50794358 ↗InjurySep 16, 2026Malposition of Device
It was reported that the patient's lead was not in the correct position. As a result, surgical intervention was undertaken on (b)(6) 2012 wherein the lead was replaced to address the issue. It is unknown which lead the allegation is against.
Patient problems: Inadequate Pain Relief
MAUDE report 50792438 ↗InjurySep 16, 2026High impedance
It was reported that the patient's leads exhibited high impedances. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790851 ↗InjuryAug 24, 2026High impedance
It was reported that the patient's thoracic lead exhibited high impedances. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the lead was explanted and replaced to address the issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50419835 ↗InjuryAug 23, 2026High impedance
It was reported the patient is not receiving effective therapy due to high impedances and unable to enter MRI mode. Surgical intervention may be pending to address the issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50394456 ↗InjuryAug 23, 2026High impedance
It was reported the patient is not receiving effective therapy due to high impedances and unable to enter MRI mode. Surgical intervention may be pending to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50394455 ↗InjuryAug 6, 2026Therapeutic or Diagnostic Output Failure
It was reported that the patient experienced ineffective therapy with their DRG and SCS systems. The T12 DRG lead was confirmed fractured by x-ray. As a result, surgical intervention may be undertaken to address the issue. It is unknown which SCS lead is at fault.
Patient problems: Inadequate Pain Relief
MAUDE report 50158750 ↗InjuryAug 6, 2026Migration
It was reported that during a routine IPG replacement, x-rays confirmed the bilateral leads migrated. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50156446 ↗InjuryAug 6, 2026Migration
It was reported that during a routine IPG replacement, x-rays confirmed the bilateral leads migrated. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50156441 ↗
Other Advanced Neuromodulation Systems, Inc. products
All Advanced Neuromodulation Systems, Inc. devices →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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