Protégé MRI™ 3771Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,997 adverse event reports that list this exact device (DI 05415067017086), received between Jun 14, 2018 and Sep 28, 2026 — classified as 1,987 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (618 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,997 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 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 50913345 ↗
• InjurySep 25, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50903251 ↗
• InjurySep 22, 2026Insufficient Device Problem Information

  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 50854820 ↗
• InjuryAug 6, 2026Wireless Communication Problem

  It was reported that patients 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 50163051 ↗
• InjuryJul 10, 2026Improper or Incorrect Procedure or Method

  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: Inadequate Pain Relief

  MAUDE report 25787669 ↗
• InjuryJul 10, 2026Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG SITE AND INEFFECTIVE THERAPY. ADDITIONALLY, THE PATIENT¿S IPG IS INOPERABLE. AS SUCH, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25787359 ↗
• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG SITE AND INEFFECTIVE THERAPY. ADDITIONALLY, THE PATIENT¿S IPG IS INOPERABLE. AS SUCH, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 25787356 ↗
• InjuryJun 25, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE IPG REQUIRED MORE THAN ONE CHARGE A DAY TO KEEP FROM BEING DEPLETED, CAUSING RECHARGE BURDEN FOR THE PATIENT. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHERE THE IPG WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25621869 ↗
• InjuryJun 2, 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 25363174 ↗
• InjuryMay 27, 2026Wireless Communication Problem

  IT WAS REPORTED THE PATIENT'S IPG WAS INOPERABLE. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25311480 ↗
• InjuryMay 27, 2026Wireless 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) 2026 WHEREIN THE IPG WAS REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25306142 ↗
• InjuryMay 22, 2026Premature Discharge of Battery; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHARGING ISSUES WITH THEIR IPG, AND AS A RESULT THE IPG BECAME INOPERABLE. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25255636 ↗
• InjuryMay 21, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS REMOVED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 25246423 ↗
• InjuryMay 19, 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 25216564 ↗
• InjuryMay 11, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD THEIR SYSTEM EXPLANTED ON AN (B)(6) 2026 FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 25142830 ↗
• 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.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25007106 ↗
• InjuryApr 13, 2026Wireless Communication Problem

  IT WAS REPORTED THE PATIENT'S IPG WAS INOPERABLE. IT IS UNKNOWN IF THE PATIENT STOPPED CHARGING THE DEVICE. SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24859055 ↗
• InjuryApr 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PAIN AT THE IPG SITE. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE SYSTEM WAS EXPLANTED.

  Patient problems: Implant Pain

  MAUDE report 24854027 ↗
• InjuryMar 24, 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 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 24680458 ↗
• InjuryMar 24, 2026Wireless Communication Problem

  IT WAS REPORTED THAT PATIENT HAD UNRESOLVED CHARGING DIFFICULTIES WITH THE IPG AND CHARGER. THE IPG BECAME INOPERABLE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE IPG WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24674298 ↗
• InjuryMar 20, 2026Wireless Communication Problem

  IT WAS REPORTED THAT THE IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES, DEEMING THE IPG INOPERABLE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24653862 ↗
• InjuryMar 19, 2026Wireless Communication Problem

  IT WAS REPORTED THAT THE IPG HAD UNRESOLVED CONNECTION ISSUE BETWEEN THE IPG AND CHARGER THAT LEAD TO RECHARGE BURDEN. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE IPG WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24646306 ↗
• InjuryFeb 27, 2026Wireless Communication Problem

  IT WAS REPORTED THE PATIENT'S IPG IS INOPERABLE. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24470704 ↗
• InjuryFeb 12, 2026Wireless 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) 2026 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24327484 ↗
• InjuryFeb 10, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PATIENT DID NOT RECHARGE THE IPG AS RECOMMENDED. AS SUCH, THE IPG BECAME INOPERABLE. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24310896 ↗

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-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-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-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-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-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-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-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-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-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