Protégé™ 3789 (UDI 05415067020833)Recalls & reported problems

St. Jude Medical, Inc. · IPG, 16-Channel Rechargeable · Class 3 · Implant

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

Quick summary

This St. Jude Protégé spinal cord stimulator is an implanted device that sends electrical pulses to relieve pain. The 446 reports often describe the implanted battery unit losing its ability to communicate with external devices, in some cases after patients did not recharge it, and many describe inadequate pain relief. There are 446 injuries and no deaths, and no recalls name this device. Reports dropped from 27 in the year before to 10 in the most recent 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: 446
Deaths reported: 0
Injuries reported: 446
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 446 adverse event reports that list this exact device (DI 05415067020833), received between Jun 11, 2018 and Jun 25, 2026 — classified as 446 injuries.

The most frequently reported specific device problem is “Wireless Communication Problem” (136 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

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

Most reported problems

Device problems

Wireless Communication Problem136
Improper or Incorrect Procedure or Method125
Adverse Event Without Identified Device or Use Problem53
Use of Device Problem50
Therapeutic or Diagnostic Output Failure22
Insufficient Device Problem Information17
Premature Discharge of Battery17
No Device Output16

Patient problems

Inadequate Pain Relief369
Failure of Implant25
No Clinical Signs, Symptoms or Conditions16
Implant Pain15
No Consequences Or Impact To Patient12
Insufficient Information9
Unspecified Infection8
Pain7

Recent adverse event reports

The 25 most recent of 446 reports, in the reporter's own words as published by the FDA.

InjuryJun 25, 2026Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE PATIENT DID NOT CHARGE THEIR IPG AS RECOMMENDED AND THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25627005 ↗
InjuryJun 10, 2026Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE PATIENT DID NOT CHARGE THEIR IPG AS RECOMMENDED AND THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHERE THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25459388 ↗
InjuryJun 8, 2026Wireless Communication Problem
IT WAS REPORTED THAT THE PATIENT'S IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. TROUBLESHOOTING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TOA DDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25437218 ↗
InjuryApr 27, 2026Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE PATIENT DID NOT CHARGE THEIR IPG AS RECOMMENDED AND THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.
Patient problems: Inadequate Pain Relief
MAUDE report 24999075 ↗
InjuryApr 7, 2026No Apparent Adverse Event
ADDITIONAL INFORMATION INDICATES THE IPG MEETS OR EXCEEDS 75% OF ITS EXPECTED LONGEVITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24808163 ↗
InjuryApr 6, 2026Wireless Communication Problem
IT WAS REPORTED THE PATIENT¿S IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. A MANUFACTURER REPRESENTATIVE CONFIRMED THE ISSUE AND THE IPG DEEMED INOPERABLE. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24794159 ↗
InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Implant Pain
MAUDE report 24714589 ↗
InjuryJan 14, 2026Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE PATIENT DID NOT CHARGE THEIR IPG AS RECOMMENDED AND THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24071490 ↗
InjuryDec 2, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT THE PATIENT'S IPG WAS INOPERABLE. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE IPG WAS EXPLANTED AND REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 23700333 ↗
InjuryNov 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED PATIENT'S SYSTEM WAS EXPLANTED AT AN UNKNOWN TIME FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 23457818 ↗
InjurySep 2, 2025Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THE PATIENT EXPERIENCED INCREASED IPG RECHARGE BURDEN. 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
MAUDE report 22947507 ↗
InjuryJul 31, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE PATIENT DID NOT CHARGE THEIR IPG AS RECOMMENDED AND THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THIS ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 22682891 ↗
InjuryJul 22, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT THE PATIENT'S IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. TROUBLESHOOTING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN IN THE FUTURE.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 22567976 ↗
InjuryJun 19, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE PATIENT DID NOT CHARGE THEIR IPG AS RECOMMENDED AND THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 22289772 ↗
InjuryJun 5, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT THE PATIENT'S IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES AND WAS DEEMED INOPERABLE. 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 22155451 ↗
InjuryJun 4, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT THE PATIENT'S IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. 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 22146910 ↗
InjuryJun 2, 2025Premature Discharge of Battery; Wireless Communication Problem; Premature Discharge of Battery; Wireless Communication Problem
IT WAS REPORTED THE PATIENT¿S IPG HAD AN INCREASED RECHARGE BURDEN. THE IPG WAS SUBSEQUENTLY EXPLANTED AND REPLACED.
Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions
MAUDE report 22122710 ↗
InjuryMay 16, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THE SCS IPG WAS NOT FUNCTIONING AND WOULD NOT HOLD A CHARGE. AS SUCH, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS REPLACED AND THERAPY RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 22037565 ↗
InjuryMay 9, 2025Wireless Communication Problem; Wireless Communication 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 IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 21997514 ↗
InjuryMay 1, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
SURGICAL INTERVENTION MAY BE UNDERTAKEN IN THE FUTURE AND HAS NOT TAKEN PLACE YET.
Patient problems: Inadequate Pain Relief
MAUDE report 21947072 ↗
InjuryMay 1, 2025Wireless Communication Problem; Wireless Communication Problem
ADDITIONAL INFORMATION RECEIVED INDICATES THAT SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. REPORTEDLY, THERAPY WAS CONFIRMED POST OPERATIVELY.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 21944749 ↗
InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION INDICATES SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. ADDITIONAL INFORMATION INDICATES, PROGRAMMING WAS DONE AROUND THE IMPEDANCES, AND EFFECTIVE THERAPY HAS BEEN RESTORED. THERE IS NO DEVICE MALFUNCTION; THEREFORE, THE LEADS ARE NO LONGER CONSIDERED REPORTABLE.
Patient problems: Implant Pain
MAUDE report 21923463 ↗
InjuryApr 28, 2025Unexpected Shutdown; Unexpected Shutdown
ADDITIONAL INFORMATION INDICATES SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. ADDITIONAL INFORMATION INDICATES, PROGRAMMING WAS DONE AROUND THE IMPEDANCES, AND EFFECTIVE THERAPY HAS BEEN RESTORED. THERE IS NO DEVICE MALFUNCTION; THEREFORE, THE LEADS ARE NO LONGER CONSIDERED REPORTABLE.
Patient problems: Inadequate Pain Relief
MAUDE report 21923461 ↗
InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Implant Pain
MAUDE report 21921291 ↗
InjuryApr 2, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT THE PATIENT'S IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 21759070 ↗

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-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-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-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-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-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-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	`05415067020833`
Brand	Protégé™
Model	3789
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	Aug 1, 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
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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