Octrode™ 3186 (UDI 05415067017246)Recalls & reported problems
St. Jude Medical, Inc. · Lead Kit, 60cm Length · Class 3 · Implant
All models of Octrode (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This is a St. Jude Medical Octrode spinal cord stimulator lead kit, an implanted pain relief device. Its reports mostly mention inadequate pain relief, leads that migrate, high electrical resistance and fractures, with some saying surgery may follow. There are 32,014 reports, including 30 deaths and 31,908 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 32,096
- Deaths reported
- 30
- Injuries reported
- 31,988
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32,096 adverse event reports that list this exact device (DI 05415067017246), received between Jun 11, 2018 and Sep 30, 2026 — classified as 30 deaths, 31,988 injuries, 77 malfunctions.
The most frequently reported specific device problem is “Migration” (9,882 reports).
14 other recalls cover devices cleared under the same FDA submission (P010032); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Migration9,882
- High impedance9,185
- Adverse Event Without Identified Device or Use Problem5,162
- Therapeutic or Diagnostic Output Failure4,512
- Fracture2,444
- Impedance Problem988
- Low impedance482
- Inappropriate/Inadequate Shock/Stimulation320
Patient problems
- Inadequate Pain Relief24,906
- No Clinical Signs, Symptoms or Conditions2,766
- Failure of Implant2,237
- Undesired Nerve Stimulation810
- No Consequences Or Impact To Patient779
- Post Operative Wound Infection733
- Unspecified Infection541
- Cerebrospinal Fluid Leakage340
Recent adverse event reports
The 25 most recent of 32,096 reports, 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 ↗InjurySep 29, 2026Fracture
Patient problems: Inadequate Pain Relief
MAUDE report 50939147 ↗OtherSep 29, 2026Therapeutic or Diagnostic Output Failure
Patient problems: Inadequate Pain Relief
MAUDE report 50938918 ↗InjurySep 29, 2026High impedance
It was reported patient experienced increasing pain and stated that she was unable to adjust the stimulation intensity due to high impedances. Surgical intervention was undertaken wherein the lead was explanted and replaced to address the issue. Therapy was restored post-op.
Patient problems: Inadequate Pain Relief
MAUDE report 50938812 ↗InjurySep 29, 2026High impedance
It was reported that the patient experienced ineffective therapy following a fall. Troubleshooting revealed high impedances on the entirety of both leads. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50938084 ↗InjurySep 29, 2026High impedance
It was reported that the patient experienced ineffective therapy following a fall. Troubleshooting revealed high impedances on the entirety of both leads. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50938081 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient's IPG site opened and the system was protruding. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the system was explanted to address the issue.
Patient problems: Erosion
MAUDE report 50937942 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient's IPG site opened and the system was protruding. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the system was explanted to address the issue.
Patient problems: Erosion
MAUDE report 50937941 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced discomfort at the occipital lead site. As such, surgical intervention took place on (b)(6) 2026 wherein the leads were repositioned to address the issue.
Patient problems: Implant Pain
MAUDE report 50937617 ↗InjurySep 29, 2026High impedance
It was reported that patient's system was unable to enter MRI mode. Troubleshooting revealed high impedances on the left lead. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the lead was replaced to address the issue. Therapy was restored post-operatively.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937615 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced discomfort at the occipital lead site. As such, surgical intervention took place on (b)(6) 2026 wherein the leads were repositioned to address the issue.
Patient problems: Implant Pain
MAUDE report 50937607 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P010032. One submission often covers many models, so check the product and lot details in each record.
- Z-0458-2026 · Oct 6, 2025 · Open, ClassifiedEterna SCS IPG (Implantable Pulse Generator), Model Number 32400
- Z-2508-2023 · Jul 18, 2023 · Open, ClassifiedProclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more ext
- Z-2507-2023 · Jul 18, 2023 · Open, ClassifiedProclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more ext
- Z-2511-2023 · Jul 18, 2023 · Open, ClassifiedInfinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensio
- Z-2509-2023 · Jul 18, 2023 · Open, ClassifiedProclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extens
- Z-2505-2023 · Jul 18, 2023 · Open, ClassifiedProclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electr
- Z-2510-2023 · Jul 18, 2023 · Open, ClassifiedInfinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensio
- Z-2506-2023 · Jul 18, 2023 · Open, ClassifiedProclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description: The implantable pulse generator (IPG) is an electronic device
- Z-2691-2017 · Jun 2, 2017 · TerminatedProclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be c
- Z-2692-2017 · Jun 2, 2017 · TerminatedProclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be c
- Z-1785-2013 · Nov 30, 2012 · TerminatedEon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger); This is a continuation of the firm's July 2012 reca
- Z-0025-2013 · Sep 4, 2012 · TerminatedThe Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode
- Z-1738-2013 · Jul 26, 2012 · TerminatedEon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or li
- Z-3091-2011 · Jun 2, 2009 · TerminatedSoftware version 3.3 for Rapid Programmer devices, Model 3832. Software version 3.3 for Rapid Programmer devices, a personal digital assistant (PDA) based programmer supporting im
Other STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF devices
- Intellis™ AdaptiveStim® 97715Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 deaths23,976 reports
- RestoreSensor™SureScan® 97714Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF6 deaths17,903 reports
- Proclaim™ 3660St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 recalls25 deaths13,336 reports
- Intellis™ AdaptiveStim® 97715Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF11,487 reports
- Precision Spectra ™ SC-1132Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF53 deaths11,269 reports
- Proclaim™ 5 EliteSt. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall10 deaths9,661 reports
- Proclaim™ 7 EliteSt. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall12 deaths7,299 reports
- Spectra WaveWriter™ SC-1160Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF31 deaths7,221 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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