NA 2311Recalls & reported problems
St. Jude Medical, Inc. · 8-channel adapter, M, 10cm · Class 3 · Implant
Quick summary
This St. Jude spinal-cord stimulation adapter is part of an implanted pain-relief system. Reports mostly describe ineffective therapy, high impedance, or lead migration, with inadequate pain relief. There are 103 adverse event reports naming it, with no deaths and 101 injuries. Reports rose to 7 in the last 12 months from none the prior 12 months. 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
- 102
- Deaths reported
- 0
- Injuries reported
- 100
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 05415067016119), received between Jun 12, 2018 and May 19, 2026 — classified as 100 injuries, 2 malfunctions.
The most frequently reported specific device problem is “High impedance” (29 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem33
- High impedance29
- Therapeutic or Diagnostic Output Failure16
- Migration8
- Insufficient Device Problem Information7
- Impedance Problem5
- Fracture3
- Use of Device Problem3
Patient problems
- Inadequate Pain Relief64
- No Consequences Or Impact To Patient7
- Implant Pain6
- Undesired Nerve Stimulation6
- No Known Impact Or Consequence To Patient4
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions3
- Unspecified Infection3
Recent adverse event reports
The 25 most recent of 102 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY WITH THE SCS SYSTEM. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED ON AN UNKNOWN DATE. IT IS UNKNOWN WHICH ADAPTER IS AT FAULT.
Patient problems: Inadequate Pain Relief
MAUDE report 25224636 ↗InjuryApr 3, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT DID NOT CHARGE THEIR IPG AS RECOMMENDED AND THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. ADDITIONALLY, THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS REPLACED ON (B)(6) 2026 TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH ADAPTER IS RESPONSIBLE FOR THIS ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24784158 ↗InjuryFeb 18, 2026Migration
IT WAS REPORTED THAT FOLLOWING A FALL THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. X-RAY IMAGING REVEALED MIGRATION OF BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEADS WERE REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24384061 ↗InjuryFeb 18, 2026Migration
IT WAS REPORTED THAT FOLLOWING A FALL THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. X-RAY IMAGING REVEALED MIGRATION OF BOTH LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE LEADS WERE REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24384056 ↗InjuryFeb 6, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE SYSTEM WAS EXPLANTED DUE TO INEFFECTIVE STIMULATION. INVESTIGATION WAS UNABLE TO IDENTIFY WHICH DEVICE ATTRIBUTED TO THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24283107 ↗InjuryJan 2, 2026High impedance
IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCES. SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH ADAPTER IS AT FAULT.
Patient problems: Inadequate Pain Relief
MAUDE report 23949731 ↗InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE IPG SITE FOLLOWING RECENT WEIGHT LOSS. AS A RESULT, THE LEAD ADAPTERS WERE REPLACED WITH A SEPARATE HEADER VIA SURGICAL INTERVENTION ON (B)(6) 2024. THERAPY WAS RESTORED POST OP.
Patient problems: Implant Pain
MAUDE report 20403745 ↗InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE IPG SITE FOLLOWING RECENT WEIGHT LOSS. AS A RESULT, THE LEAD ADAPTERS WERE REPLACED WITH A SEPARATE HEADER VIA SURGICAL INTERVENTION ON (B)(6) 2024. THERAPY WAS RESTORED POST OP.
Patient problems: Implant Pain
MAUDE report 20403399 ↗InjuryApr 17, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
ADDITIONAL INFORMATION RECEIVED REPORTS THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION IN WHICH THEIR SYSTEM WAS EXPLANTED.
Patient problems: Inadequate Pain Relief
MAUDE report 19128501 ↗InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE LEFT SKULL. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE ADAPTER WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Unspecified Infection
MAUDE report 17561524 ↗InjuryJun 7, 2023High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-02713. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING UNCOMFORTABLE STIMULATION SINCE THE IMPLANT OF THEIR DEVICE AND THE PATIENT'S ADAPTERS WERE FOUND TO BE EXHIBITING HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 IN WHICH THE ADAPTERS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Undesired Nerve Stimulation
MAUDE report 17083948 ↗InjuryJun 7, 2023High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2023-02715. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING UNCOMFORTABLE STIMULATION SINCE THE IMPLANT OF THEIR DEVICE AND THE PATIENT'S ADAPTERS WERE FOUND TO BE EXHIBITING HIGH IMPEDANCES. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 IN WHICH THE ADAPTERS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Undesired Nerve Stimulation
MAUDE report 17083946 ↗InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-02515, 1627487-2022-02516. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG POCKET DUE TO THE LOCATION AND ADAPTORS. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2022 WHEREIN THE IPG AND ADAPTERS WERE EXPLANTED AND REPLACED WITH A NEW IPG ADDRESSING THE ISSUE. THE IPG WAS REPOSITIONED IN THE SAME IPG POCKET.
Patient problems: Implant Pain
MAUDE report 14254094 ↗InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-02515. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-02517. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG POCKET DUE TO THE LOCATION AND ADAPTORS. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2022 WHEREIN THE IPG AND ADAPTERS WERE EXPLANTED AND REPLACED WITH A NEW IPG ADDRESSING THE ISSUE. THE IPG WAS REPOSITIONED IN THE SAME IPG POCKET.
Patient problems: Implant Pain
MAUDE report 14254058 ↗InjuryFeb 7, 2022Use of Device Problem; Use of Device Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-00703. IT WAS REPORTED THAT DURING A PROCEDURE PHYSICIAN HAD TO CUT THROUGH ONE OF THE ADAPTERS. AS SUCH ONE OF THE ADAPTERS WAS EXPLANTED AND REPLACED WITH A NEW ONE. PATIENT WAS STABLE AND NO OTHER COMPLICATION. BOTH THE ADAPTERS ARE REPORTED AS IT IS UNKNOWN WHICH ONE WAS LIABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13472678 ↗InjuryFeb 7, 2022Use of Device Problem; Use of Device Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-00701. IT WAS REPORTED THAT DURING A PROCEDURE, PHYSICIAN HAD TO CUT THROUGH ONE OF THE ADAPTERS. AS SUCH ONE OF THE ADAPTERS WAS EXPLANTED AND REPLACED WITH A NEW ONE. PATIENT WAS STABLE AND NO OTHER COMPLICATION. BOTH THE ADAPTERS ARE REPORTED AS IT IS UNKNOWN WHICH ONE WAS LIABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13472675 ↗InjuryDec 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-19212. IT WAS REPORTED THAT PATIENT EXPERIENCED UNCOMFORTABLE STIMULATION. REPROGRAMING WAS NOT ABLE TO RESOLVE THE ISSUE. SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE.
Patient problems: Undesired Nerve Stimulation
MAUDE report 13082856 ↗InjuryDec 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-19213. IT WAS REPORTED THAT PATIENT EXPERIENCED UNCOMFORTABLE STIMULATION. REPROGRAMING WAS NOT ABLE TO RESOLVE THE ISSUE. SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE.
Patient problems: Undesired Nerve Stimulation
MAUDE report 13082854 ↗MalfunctionSep 30, 2021Fracture; High impedance; Therapeutic or Diagnostic Output Failure; Fracture; High impedance; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-17317. IT WAS REPORTED THE PATIENT LOST THERAPY IN THE RIGHT LEG. A BREAK IN THE WIRE WAS NOTED AT THE EXTENSIONS. REPROGRAMMING ALLOWED THE PATIENT TO CAPTURE SOME COVERAGE TO THE RIGHT LEG. NEXT STEPS ARE BEING DETERMINED.
Patient problems: Inadequate Pain Relief
MAUDE report 12554410 ↗MalfunctionSep 30, 2021Fracture; High impedance; Therapeutic or Diagnostic Output Failure; Fracture; High impedance; Therapeutic or Diagnostic Output Failure
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-17318. IT WAS REPORTED THE PATIENT LOST THERAPY IN THE RIGHT LEG. A BREAK IN THE WIRE WAS NOTED AT THE EXTENSIONS. REPROGRAMMING ALLOWED THE PATIENT TO CAPTURE SOME COVERAGE TO THE RIGHT LEG. NEXT STEPS ARE BEING DETERMINED.
Patient problems: Inadequate Pain Relief
MAUDE report 12554404 ↗InjuryAug 6, 2021High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-16163. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. DIAGNOSTICS INDICATED OVER HALF OF THE CONTACTS WERE HIGH. IN TURN, THE COMPETITOR LEAD AND ABBOTT ADAPTERS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 12288291 ↗InjuryAug 6, 2021High impedance; High impedance
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-16162. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. DIAGNOSTICS INDICATED OVER HALF OF THE CONTACTS WERE HIGH. IN TURN, THE COMPETITOR LEAD AND ABBOTT ADAPTERS WERE EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 12288288 ↗InjuryMay 10, 2021Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT DURING A COMPETITOR REPLACEMENT THE PHYSICIAN ATTEMPTED TO INSERT THE COMPETITOR LEAD INTO THE ABBOTT ADAPTER, BUT IT WOULD NOT INSERT SINCE IT WAS THE WRONG TYPE OF ADAPTER. THE PHYSICIAN OPTED TO ABORT THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11797440 ↗InjuryMar 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-01476. IT WAS REPORTED THAT SURGERY MAY HAVE OCCURRED TO EXPLANT THE SYSTEM. THE REASON FOR EXPLANT AND DATE OF EXPLANT ARE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 11397029 ↗InjuryFeb 28, 2021Migration; Migration
RELATED MANUFACTURER REFERENCE NUMBERS: 3006705815-2021-00896, 1627487-2021-01706. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG POCKET SITE. IMAGING REVEALED THAT THE LEAD ADAPTERS HAD MIGRATED UNDER THE GENERATOR. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2021 WHEREING THE IPG AND ADAPTERS WERE RELOCATED RESOLVING THE ISSUE. NO PRODUCTS WERE IMPLANTED OR EXPLANTED.
Patient problems: Implant Pain
MAUDE report 11391100 ↗
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-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-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-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-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-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-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-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-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
- Octrode™ 3186St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF30 deaths32,096 reports
- 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.