Protégé™ 3789 (UDI 05414734405690)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 Medical Protégé spinal cord stimulator has 1,229 adverse event reports, including 1 death and 1,223 injuries. Most reports mention inadequate pain relief, and others describe the implanted pulse generator losing its wireless connection to external devices, with some leading to surgery to remove or replace it. No recalls name this device. Reports in the last 12 months (20) are fewer than in the 12 months before (45).

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: 1,226
Deaths reported: 1
Injuries reported: 1,220
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1,226 adverse event reports that list this exact device (DI 05414734405690), received between Jun 11, 2018 and Jul 31, 2026 — classified as 1 death, 1,220 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (377 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

Improper or Incorrect Procedure or Method377
Wireless Communication Problem326
Adverse Event Without Identified Device or Use Problem157
Use of Device Problem111
Therapeutic or Diagnostic Output Failure102
Insufficient Device Problem Information75
Premature Discharge of Battery44
No Device Output38

Patient problems

Inadequate Pain Relief974
No Consequences Or Impact To Patient62
No Clinical Signs, Symptoms or Conditions42
Failure of Implant40
Pain35
Insufficient Information32
Discomfort31
Implant Pain27

Recent adverse event reports

The 25 most recent of 1,226 reports, in the reporter's own words as published by the FDA.

InjuryJul 31, 2026Improper or Incorrect Procedure or Method; Wireless Communication Problem
It was reported that the patient's IPG became unable to communicate with external devices. As a result, surgical intervention may be undertaken in the future.
Patient problems: Inadequate Pain Relief
MAUDE report 50105498 ↗
InjuryJun 11, 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 TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25470801 ↗
InjuryMay 28, 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 25322004 ↗
InjuryFeb 27, 2026Wireless Communication Problem
IT WAS REPORTED PATIENT'S THORACIC LEAD HAS HIGH IMPEDANCES. PATIENT WAS UNABLE TO CHARGE THE IPG SINCE 2024. TO ADDRESS THE ISSUES, SURGICAL INTERVENTION MAY BE PENDING.
Patient problems: Inadequate Pain Relief
MAUDE report 24474871 ↗
InjuryFeb 16, 2026Wireless Communication Problem
IT WAS REPORTED THE PATIENT'S IPG WAS INOPERABLE. IT IS UNKNOWN IF THE PATIENT STOPPED CHARGING THE DEVICE. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS ESTABLISHED.
Patient problems: Inadequate Pain Relief
MAUDE report 24347451 ↗
InjuryJan 27, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD THEIR IPG EXPLANTED ON AN UNKNOWN DATE TO HAVE PAIN PUMP IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 24193687 ↗
InjuryJan 9, 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 ON (B)(6) 2025 TO ADDRESS THE ISSUE. DURING IPG REPLACEMENT THE PATIENTS LEAD HAD A HIGH IMPEDANCE. AS A RESULT, THE LEAD WAS ALSO REPLACED ON (B)(6) 2025 TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24027712 ↗
InjuryJan 2, 2026Wireless Communication Problem
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 23950426 ↗
InjuryJan 2, 2026Wireless Communication Problem
IT WAS REPORTED THAT THE PATIENT'S IPG IS INOPERABLE. SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 23947863 ↗
InjuryDec 29, 2025Improper or Incorrect Procedure or Method; Wireless Communication Problem; Improper or Incorrect Procedure or Method; Wireless Communication Problem
ADDITIONAL INFORMATION INDICATES THAT THE PATIENT STOPPED CHARGING DUE TO AN UNKNOWN REASON.
Patient problems: Inadequate Pain Relief
MAUDE report 23917043 ↗
InjuryDec 17, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
ADDITIONAL INFORMATION INDICATES SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 23832232 ↗
InjuryDec 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION ON AN UNKNOWN DATE WHEREIN THE SYSTEM WAS EXPLANTED FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 23761599 ↗
InjuryDec 4, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2025 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.
Patient problems: Inadequate Pain Relief
MAUDE report 23719576 ↗
InjuryDec 3, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
ADDITIONAL INFORMATION INDICATES THERE IS NO ALLEGATION OF DEVICE DEFICIENCY. REPLACEMENT OF THE DEVICE IS ELECTIVE TO HAVE AN IMAGING PROCEDURE PERFORMED AS THE PATIENT IS NOT IMPLANTED WITH MRI CONDITIONAL SYSTEM REQUIRED FOR PATIENT¿S IMAGING NEEDS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23712257 ↗
InjuryDec 3, 2025Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THE PATIENT¿S IPG HAD AN INCREASED RECHARGE BURDEN. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS REPLACED ON (B)(6) 2025 TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23707293 ↗
InjuryNov 24, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THE PATIENT'S IPG WAS INOPERABLE. SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE IPG WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS CONFIRMED.
Patient problems: Inadequate Pain Relief
MAUDE report 23631695 ↗
InjuryNov 18, 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 MAY BE PENDING TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 23583086 ↗
InjuryOct 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENT STOPPED USING THE STIMULATOR FOR AN UNKNOWN REASON. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 23426033 ↗
InjuryOct 24, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
DEVICE IS NO LONGER REPORTABLE AS THERE IS NO ALLEGATION AGAINST THE DEVICE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23377588 ↗
InjuryOct 15, 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 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 23303657 ↗
InjurySep 4, 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 MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 22974662 ↗
InjurySep 3, 2025Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT THE PATIENT'S IPG WAS INOPERABLE DUE TO NOT HOLDING A CHARGE. 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 22959921 ↗
InjurySep 3, 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 MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 22954771 ↗
InjurySep 2, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED PATIENT'S IPGS BECAME INOPERABLE DUE TO PATIENT STOPPED CHARGING. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUES.
Patient problems: Inadequate Pain Relief
MAUDE report 22935545 ↗
InjurySep 2, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THE PATIENT DID NOT RECHARGE THE IPG AS RECOMMENDED. IN TURN, THE IPG BECAME INOPERABLE. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 22932764 ↗

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-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-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-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-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-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-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-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	`05414734405690`
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.

How reports and recalls are matched · Editorial policy · Report an error on this page