Proclaim™ 3662Recalls & reported problems

Summary

The FDA's MAUDE database contains 867 adverse event reports that list this exact device (DI 05415067031426), received between Nov 12, 2020 and Sep 28, 2026 — classified as 1 death, 828 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (331 reports).

2 FDA recall records name this device's identifier, 2 still open.

13 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. 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-2360-2024 · Root cause: Vendor change control · Recall details · FDA record ↗

2. Jul 18, 2023Open, Classified

   Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

   Z-2506-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 867 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Insufficient Device Problem Information

  It was reported the patient's system was explanted. Reason and date of explant are unknown.

  Patient problems: Insufficient Information

  MAUDE report 50921849 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Implant Pain

  MAUDE report 50875965 ↗
• InjurySep 23, 2026Wireless Communication Problem

  It was reported that the patient's IPG became inoperable following an unrelated surgery. Reportedly, the IPG was not set into surgery mode prior to the surgery. Troubleshooting was unable to resolve the issue. As such, surgical intervention took place wherein the IPG was explanted and replaced with a new IPG to address the issue. Therapy was confirmed post op.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50863461 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Implant Pain

  MAUDE report 50831012 ↗
• InjurySep 18, 2026Premature Discharge of Battery

  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: Inadequate Pain Relief

  MAUDE report 50820704 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient experienced pain at the IPG site. In turn, surgical intervention was undertaken on 10Sep2026 wherein the IPG was implanted slightly deeper in the pocket to address the issue.

  Patient problems: Implant Pain

  MAUDE report 50820622 ↗
• InjurySep 17, 2026Wireless Communication Problem

  It was reported that the IPG was not placed into MRI 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 50808697 ↗
• InjurySep 16, 2026Insufficient Device Problem Information

  Patient problems: Inadequate Pain Relief

  MAUDE report 50793990 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was experiencing pain at the implant site following a fall. As a result, surgical intervention was undertaken on (b)(6) 2026 where IPG was removed and replaced with a smaller profile as well as relocating to a new pocket to address the issue.

  Patient problems: Implant Pain

  MAUDE report 50756287 ↗
• InjuryAug 5, 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. 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. Therapy was restored post procedure.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50142789 ↗
• InjuryAug 4, 2026Wireless Communication Problem

  It was reported that following an unrelated surgical procedure wherein the devices were not placed into surgery mode, the IPGs 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 IPGs were explanted and replaced to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50133539 ↗
• InjuryJul 27, 2026Temperature Problem

  It was reported that the patient lost therapy and experienced pocket heating after touching an electric fence. As a result, surgical intervention was undertaken to remove and replace the system.

  Patient problems: Burning Sensation

  MAUDE report 50045107 ↗
• InjuryJul 27, 2026Premature Discharge of Battery

  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.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50031920 ↗
• InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT EXPERIENCED PAIN AT THE IPG SITE. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.

  Patient problems: Implant Pain

  MAUDE report 25628533 ↗
• InjuryJun 13, 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. TROUBLESHOOTING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN IPG WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25495727 ↗
• InjuryJun 1, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD THEIR SCS AND DRG SYSTEMS REMOVED FOR AN UNKNOWN REASON AT AN UNKNOWN DATE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 25356420 ↗
• MalfunctionMay 28, 2026Wireless Communication Problem

  IT WAS REPORTED THE PATIENT HAD A NECK FUSION ON (B)(6) 2026 WHEREIN THE DEVICE WAS NOT PLACED IN SURGERY MODE. SUBSEQUENTLY, THE PATIENT WAS UNABLE TO CONNECT TO THE IPG AND THE PATIENT CONTROLLER WAS DISPLAYING AN ERROR MESSAGE SINCE THE PROCEDURE. TROUBLESHOOTING WAS ABLE TO RESOLVE THE ISSUE AND THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25318546 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS EXPERIENCING PAIN AT BOTH IPG SITES DUE TO WEIGHT LOSS. SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2026 WHEREIN BOTH IPG¿S WERE BURIED DEEPER WITHIN THE SAME POCKET SITES TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 25315978 ↗
• InjuryMay 26, 2026Insufficient Device Problem Information

  IT WAS REPORTED PATIENT'S SYSTEM WAS EXPLANTED AN UNKNOWN TIME DUE TO AN UNKNOW REASON.

  Patient problems: Insufficient Information

  MAUDE report 25283596 ↗
• InjuryMay 22, 2026Premature Discharge of Battery

  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 WHEREIN THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25262122 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT EXPERIENCED DISCOMFORT AT THE IPG SITE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN THE IPG WAS REPOSITIONED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 25221930 ↗
• InjuryApr 21, 2026Migration

  IT WAS REPORTED THE IPG HAD MIGRATED CAUSING THE PATIENT DISCOMFORT. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED, REPLACED AND RELOCATED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 24937719 ↗
• InjuryApr 16, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT RECEIVED THE ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE STATING THAT THE IPG IS NEARING END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24897305 ↗
• InjuryApr 10, 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 MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 24842446 ↗
• InjuryApr 6, 2026Premature Discharge of Battery

  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 24794016 ↗

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-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