Proclaim™ 5Recalls & reported problems

St. Jude Medical, Inc. · Inplantable Pulse Generator · Class 3 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This St. Jude Proclaim 5 spinal cord stimulator has 224 adverse event reports, including 209 injuries and 15 malfunctions, and no deaths. Most reports describe inadequate pain relief, and many describe battery problems or lost wireless contact with programmers. There is 1 open recall, begun in May 2024, over a battery that may run out sooner than the labeling says. Reports fell from 20 in the prior year to 7 in the latest year.

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: 223
Deaths reported: 0
Injuries reported: 208
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 223 adverse event reports that list this exact device (DI 05415067020208), received between Aug 28, 2018 and Jul 18, 2026 — classified as 208 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (76 reports).

1 FDA recall record name this device's identifier, 1 still open.

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

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

May 16, 2024Open, Classified
The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
Z-2359-2024 · Root cause: Vendor change control · FDA record ↗

Most reported problems

Device problems

Battery Problem76
Adverse Event Without Identified Device or Use Problem59
Wireless Communication Problem57
Insufficient Device Problem Information18
Migration7
Therapeutic or Diagnostic Output Failure6
Application Program Freezes or Fails to Launch5
Premature Discharge of Battery4

Patient problems

Inadequate Pain Relief135
Failure of Implant63
Implant Pain32
No Clinical Signs, Symptoms or Conditions11
Insufficient Information7
No Consequences Or Impact To Patient7
Post Operative Wound Infection6
Discomfort5

Recent adverse event reports

The 25 most recent of 223 reports, in the reporter's own words as published by the FDA.

InjuryJul 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHOCKING SENSATION AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Implant Pain
MAUDE report 25866307 ↗
InjuryMay 29, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD THEIR SYSTEM EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 25337898 ↗
InjuryMar 13, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD THEIR IPG EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 24598509 ↗
MalfunctionJan 6, 2026Wireless Communication Problem
IT WAS REPORTED THAT FOLLOWING AN UNRELATED SURGICAL PROCEDURE WHEREIN THE DEVICE WAS NOT PLACED INTO SURGERY MODE, THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. A MANUFACTURER REPRESENTATIVE WAS ABLE TO RECOVER THE IPG VIA TROUBLESHOOTING. THERAPY WAS RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 23985281 ↗
InjuryDec 22, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT FOLLOWING AN UNRELATED SURGICAL PROCEDURE WHEREIN THE DEVICE WAS NOT PLACED INTO SURGERY MODE, THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. TROUBLESHOOTING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 23871952 ↗
InjuryNov 21, 2025Premature Discharge of Battery; Insufficient Device Problem Information; Premature Discharge of Battery; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT¿S IPG HAD REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 23623687 ↗
InjurySep 17, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT FOLLOWING AN UNRELATED SURGICAL PROCEDURE WHEREIN THE DEVICE WAS NOT PLACED INTO SURGERY MODE, THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. TROUBLESHOOTING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 23078492 ↗
MalfunctionSep 9, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT FOLLOWING AN UNRELATED SURGICAL PROCEDURE WHEREIN BOTH DEVICES WERE PLACED INTO SURGERY MODE, THE THORACIC AND CERVICAL IPGS BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. TROUBLESHOOTING WAS ABLE TO RESOLVE THE CERVICAL IPG, BUT THE THORACIC IPG WAS NOT RECOVERED. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE THORACIC IPG.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 23004399 ↗
InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DUE TO A RECENT WEIGHT LOSS, PATIENT BEGAN EXPERIENCING PAIN AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 DURING WHICH THE PHYSICIAN REPLACED AND REPOSITIONED THE PATIENT'S SCS IPG TO ADDRESS THE ISSUE.
Patient problems: Implant Pain
MAUDE report 22953153 ↗
InjuryAug 7, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PATIENT RECEIVED A LOW BATTERY WARNING. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST-OP.
Patient problems: Failure of Implant
MAUDE report 22745361 ↗
InjuryJun 4, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PATIENT¿S IPG HAD REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 22143433 ↗
InjuryMar 26, 2025Battery Problem; Battery Problem
IT WAS REPORTED THE PATIENT LOST THERAPY AS THE IPG REACHED END OF SERVICE (EOS). IT IS UNKNOWN IF THE IPG DEPLETED PREMATURELY. SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE IPG WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS CONFIRMED.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 21698405 ↗
InjuryMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT EXPERIENCED DISCOMFORT LOCATED AT THE IPG SITE DUE TO WEIGHT LOSS. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Implant Pain
MAUDE report 21677685 ↗
InjuryMar 21, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PATIENT'S IPG REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE IPG WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 21668856 ↗
InjuryMar 18, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PATIENT'S IPG REACHED END OF LIFE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 21636868 ↗
InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING IRRITATION/DISCOMFORT AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.
Patient problems: Implant Pain
MAUDE report 21632880 ↗
InjuryMar 11, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT FOLLOWING AN UNRELATED SURGICAL PROCEDURE WHEREIN IT IS UNKNOWN IF THE DEVICE WAS NOT PLACED INTO SURGERY MODE, THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. TROUBLESHOOTING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 21579234 ↗
InjuryMar 10, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PATIENT¿S IPG HAD REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 21566688 ↗
InjuryFeb 19, 2025Battery Problem; Battery Problem
ADDITIONAL INFORMATION RECEIVED INDICATED THAT PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE IPG WAS EXPLANTED AND REPLACED. REPORTEDLY EFFECTIVE THERAPY WAS RESTORED.
Patient problems: Failure of Implant
MAUDE report 21412686 ↗
InjuryFeb 18, 2025Battery Problem; Battery Problem
IT WAS REPORTED PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2025 DURING WHICH THE IPG WAS EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST-OP.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 21405479 ↗
InjuryFeb 5, 2025Battery Problem; Battery Problem
IT WAS REPORTED THE PATIENT LOST THERAPY AS THE IPG REACHED END OF SERVICE (EOS). IT IS UNKNOWN IF THE IPG DEPLETED PREMATURELY. SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE IPG WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS CONFIRMED.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 21314065 ↗
InjuryFeb 4, 2025Wireless Communication Problem; Wireless Communication Problem
ADDITIONAL INFORMATION RECEIVED INDICATES SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE IPG WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 21304063 ↗
InjuryJan 31, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PATIENT BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN IPG WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 21282964 ↗
InjuryJan 9, 2025Wireless Communication Problem; Wireless Communication Problem
ADDITIONAL INFORMATION RECEIVED INDICATES, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2025, WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 21108790 ↗
InjuryNov 26, 2024Wireless Communication Problem; Wireless Communication Problem
ADDITIONAL INFORMATION INDICATES SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2024, WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 20777876 ↗

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, Classified
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Z-2508-2023 · Jul 18, 2023 · Open, Classified
Proclaim 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-2511-2023 · Jul 18, 2023 · Open, Classified
Infinity 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, Classified
Proclaim 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-2506-2023 · Jul 18, 2023 · Open, Classified
Proclaim" 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-2507-2023 · Jul 18, 2023 · Open, Classified
Proclaim 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, Classified
Proclaim 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, Classified
Infinity 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-2691-2017 · Jun 2, 2017 · Terminated
Proclaim 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 · Terminated
Proclaim 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 · Terminated
Eon 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 · Terminated
The 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 · Terminated
Eon - 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 · Terminated
Software 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

Device details

UDI-DI	`05415067020208`
Brand	Proclaim™
Model	5
Catalog no.	3661
Company	St. Jude Medical, Inc.
Product code	LGW · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Class	Class 3
FDA submission	P010032
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jan 9, 2023

Device type (GMDN): Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

An electrically-powered, implantable component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation system intended to deliver electrical impulses to the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) via percutaneously implanted electrodes (not included) to relieve acute and/or chronic intractable pain (analgesia). The device is programmed, controlled, and charged telemetrically by external devices.

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All STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF devices →

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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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