Proclaim™ 7Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 05415067020239), received between Jul 19, 2018 and Apr 29, 2026 — classified as 1 death, 65 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (22 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.

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-2361-2024 · Root cause: Vendor change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2026Wireless Communication Problem

  IT WAS REPORTED THAT FOLLOWING AN UNRELATED SURGICAL PROCEDURE WHEREIN IT IS UNKNOWN IF THE IPG PLACED INTO SURGERY MODE, 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 25036105 ↗
• InjuryJan 20, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION ON AN UNKNOWN DATE WHEREIN THE IPG WAS EXPLANTED FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 24121430 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED DISCOMFORT AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN IPG POCKET WAS REVISED AND THE IPG WAS SUTURED IN TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 21969847 ↗
• InjuryNov 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED DISCOMFORT AT IPG SITE. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED, REPLACED AND RELOCATED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 20767539 ↗
• InjuryOct 22, 2024Battery 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) 2024, WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant

  MAUDE report 20507903 ↗
• InjurySep 11, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THE DEVICE WAS AT THE END OF SERVICE (EOS) WITH 2.75V AND IT IS UNKNOWN IF THE DEVICE DEPLETED PREMATURELY. SURGICAL INTERVENTION TOOK PLACE WHERE THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. EFFECTIVE STIMULATION WAS RESTORED.

  Patient problems: Failure of Implant

  MAUDE report 20195929 ↗
• InjuryJun 13, 2024Battery Problem; Battery Problem

  SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 19533983 ↗
• InjuryMar 15, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG HAS REACHED END OF LIFE. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant; Movement Disorder

  MAUDE report 18915865 ↗
• InjuryFeb 26, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THE PATIENT HAD THE SCS IPG REPLACED DUE TO RECEIVING AN ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY.

  Patient problems: Failure of Implant

  MAUDE report 18777714 ↗
• InjuryFeb 19, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG HAD REACHED END OF LIFE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE PATIENT'S IPG WAS EXPLANTED AND REPLACED WITH A COMPETITOR BRAND IPG(MEDTRONIC).

  Patient problems: Failure of Implant; Movement Disorder

  MAUDE report 18735482 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MANUFACTURER REFERENCE NUMBER: 1627487-2024-00641 IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT AT IPG SITES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHERE THE IPGS WERE REPLACED TO ADDRESS THE ISSUE. EFFECTIVE THERAPY RESTORED POST OP.

  Patient problems: Implant Pain

  MAUDE report 18692220 ↗
• MalfunctionJan 17, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG HAD ENTERED SERVICE APP MODE FOLLOWING AN UNRELATED PROCEDURE BUT WAS RECOVERED, RESOLVING THE ISSUE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 18529015 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO RESOLVE THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 18193280 ↗
• InjuryOct 30, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG HAD RECEIVED THE ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE PATIENT'S IPG WAS EXPLANTED, REPLACED, AND THERAPY WAS RESTORED.

  Patient problems: Failure of Implant

  MAUDE report 18034727 ↗
• InjurySep 21, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THE DEVICE DISPLAYED THE END OF SERVICE (EOS) MESSAGE AND IT IS UNKNOWN IF THE DEVICE DEPLETED PREMATURE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN THE IPG WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.

  Patient problems: Failure of Implant; Inadequate Pain Relief; Movement Disorder

  MAUDE report 17789480 ↗
• InjurySep 7, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG HAD REACHED END OF LIFE. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: Failure of Implant; Movement Disorder

  MAUDE report 17700973 ↗
• InjurySep 6, 2023Battery 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) 2023 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17687986 ↗
• InjuryAug 31, 2023Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNRELATED SURGERY AND DID NOT PLACE THE IPG INTO SURGERY MODE. AS A RESULT, THE IPG BECAME INOPERABLE. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17662084 ↗
• InjuryJun 23, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG BECAME DEPLETED. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17195518 ↗
• InjuryJun 9, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING UNCOMFORTABLE THERAPY. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE IPG WAS EXPLANTED.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 17101008 ↗
• InjuryMay 23, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENTS IPG HAD REACHED ITS END OF SERVICE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023, WHERE THE IPG WAS EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST-OP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16989565 ↗
• InjuryApr 17, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG HAS REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION WHERE THE IPG WAS EXPLANTED AND REPLACED OCCURRED TO ADDRESS THE ISSUE. REPORTEDLY, THERAPY WAS CONFIRMED POSTOP.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 16756032 ↗
• InjuryMar 30, 2023Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNRELATED SURGICAL PROCEDURE. IT IS UNCLEAR IF THE PATIENT PLACED IPG INTO SURGERY MODE AS RECOMMENDED. THEREAFTER, THE IPG FAILED TO ESTABLISH COMMUNICATION WITH EXTERNAL DEVICE. SURGICAL INTERVENTION MAY TAKE PLACE AT A FUTURE DATE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16645681 ↗
• InjuryJan 18, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS SHOWING THE LOW BATTERY MESSAGE SOONER THAN EXPECTED. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023, WHERE THE IPG WAS EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST-OP.

  Patient problems: Failure of Implant

  MAUDE report 16191461 ↗
• InjuryDec 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT'S DBS EXTENSIONS WERE TWISTED AND CAUSING A SIZEABLE KNOT AROUND THE IPG SITE, BUT THE PATIENT STILL HAS EFFECTIVE THERAPY. SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2022 WHERE THE DEVICE WAS REVISED TO ADDRESS THE ISSUE.

  Patient problems: Twiddlers Syndrome

  MAUDE report 15928549 ↗

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-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-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-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-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-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-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-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