Proclaim™ 3665Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05415067023247), received between Jul 4, 2018 and Jul 27, 2023 — classified as 18 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Premature Elective Replacement Indicator” (5 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-2362-2024 · Root cause: Vendor change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2023Battery Problem; Battery Problem

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

  Patient problems: Inadequate Pain Relief

  MAUDE report 17408175 ↗
• InjuryJan 12, 2023Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THE PATIENT'S IPG WOULD NOT COMMUNICATE WITH THE CHARGER, AND IS UNABLE TO CHARGE. SURGICAL INTERVENTION IS PENDING TO ADDRESS THIS ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16147391 ↗
• InjuryFeb 3, 2022No Apparent Adverse Event; Wireless Communication Problem; No Apparent Adverse Event; Wireless Communication Problem

  IT WAS REPORTED THE PATIENTS IPG REACHED END OF LIFE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13440203 ↗
• InjurySep 15, 2021Battery Problem; No Apparent Adverse Event; Battery Problem; No Apparent Adverse Event

  IT WAS REPORTED THE IPG HAD REACHED END OF LIFE. IN TURN, THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant; Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12476272 ↗
• InjurySep 15, 2021Battery Problem; No Apparent Adverse Event; Battery Problem; No Apparent Adverse Event

  IT WAS REPORTED THE IPG HAD REACHED END OF LIFE. IN TURN, THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant; Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12476267 ↗
• InjuryJun 9, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE WRONG IPG (NON MRI) WAS ACCIDENTALLY GIVEN TO THE PHYSICIAN FOR AN IMPLANT. AS A RESULT, SURGICAL INTERVENTION OCCURRED WHEREIN THE IPG WAS EXPLANTED AND REPLACED WITH THE CORRECT (MRI COMPATIBLE) IPG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971315 ↗
• InjurySep 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S IPG WAS INOPERABLE. AS A RESULT, THE IPG WAS EXPLANTED AND REPLACED. THERAPY WAS RESTORED FOLLOWING THE PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10601580 ↗
• InjuryAug 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR WAS SHOWING END OF LIFE. PATIENT LOST STIMULATION AS A RESULT. THE DEVICE WAS EXPLANTED, AND A NEW DEVICE WAS IMPLANTED. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. PATIENT WAS STABLE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10393861 ↗
• InjuryJul 6, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT POST PROCEDURE, IT WAS OBSERVED THAT THE INCORRECT DEVICE MODEL WAS IMPLANTED IN THE PATIENT. THE DEVICE WAS EXPLANTED, AND A NEW DEVICE WAS IMPLANTED. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10237343 ↗
• InjuryJul 1, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT POST PROCEDURE, UPON PROGRAMMING OF THE DEVICE IT WAS OBSERVED THAT THE INCORRECT DEVICE MODEL WAS IMPLANTED IN THE PATIENT. THE DEVICE WAS EXPLANTED, AND A NEW DEVICE WAS IMPLANTED. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10217527 ↗
• MalfunctionOct 7, 2019Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  IT WAS REPORTED THAT DIAGNOSTICS INDICATED THE ELECTIVE REPLACEMENT INDICATOR (ERI) TRIGGERED EARLIER THAN INTENDED. THE WIRELESS SOFTWARE UPDATE WAS PERFORMED CLEARING THE ERI MESSAGE. THE DEVICE IS PROVIDING THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9162409 ↗
• InjuryAug 8, 2019Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THE PATIENT UNDERWENT A SURGICAL PROCEDURE FOR A WOUND CLEANING IN HER FOOT. REPORTEDLY, AFTER THE PROCEDURE THE SCS SYSTEM PATIENT CONTROLLER (PC) NO LONGER COMMUNICATED WITH THE SCS IPG. THE SYSTEM HAD ONLY BEEN SWITCHED OFF, BUT NOT SET TO SURGERY MODE. A COMPANY REPRESENTATIVE ATTEMPTED TO CONNECT WITH CLINICAL PROGRAMMER BUT A MESSAGE: "UNABLE TO CONNECT TO THE GENERATOR. A PROBLEM HAS BEEN DETECTED..." WAS DISPLAYED. CONSEQUENTLY, SURGICAL INTERVENTION MAY BE NECESSARY TO REPLACE THE PATIENT'S SCS IPG.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8876204 ↗
• InjuryJul 26, 2019Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE PATIENT COULD NO LONGER CONNECT WITH THEIR IPG AFTER AN UNRELATED PROCEDURE. AS A RESULT, SURGICAL INTERVENTION WAS TAKEN TO REPLACE THE IPG.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8832808 ↗
• InjuryMar 20, 2019Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  IT WAS REPORTED THAT DIAGNOSTICS INDICATED THE ELECTIVE REPLACEMENT INDICATOR (ERI) TRIGGERED EARLIER THAN INTENDED. THE DEVICE HAD THE APPROPRIATE LEVEL OF BATTERY VOLTAGE TO PROVIDE THERAPY. THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8436411 ↗
• InjuryFeb 28, 2019Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  IT WAS REPORTED THE PATIENT'S PHYSICIAN REPLACED THE SCS IPG. REPORTEDLY, THE SCS PROGRAMMER DID NOT SHOW THE CORRECT BATTERY CAPACITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8380592 ↗
• InjuryJan 24, 2019Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED COMMUNICATION ISSUES WITH THEIR IPG. AS A RESULT, THE IPG WAS REPLACED. ISSUE HAS BEEN RESOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8276652 ↗
• InjuryOct 3, 2018Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  FOLLOW UP INFORMATION IDENTIFIED POSTOPERATIVELY, EFFECTIVE THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 7930405 ↗
• InjurySep 28, 2018Premature End-of-Life Indicator; Premature Elective Replacement Indicator; Premature End-of-Life Indicator; Premature Elective Replacement Indicator

  IT WAS REPORTED (BELGIUM) THE DEVICE DISPLAYED THE END OF SERVICE (EOS) MESSAGE. THE PATIENT IS NOT RECEIVING THERAPY AND WILL LIKELY REQUIRE SURGICAL INTERVENTION. AS A RESULT, THE PHYSICIAN EXPLANTED AND REPLACED THE PATIENT¿S IPG WITH A NEW MODEL, RESOLVING THE ISSUE.

  Patient problems: Inadequate Pain Relief; No Consequences Or Impact To Patient

  MAUDE report 7918822 ↗
• MalfunctionSep 25, 2018Premature Elective Replacement Indicator; Premature Elective Replacement Indicator

  IT WAS REPORTED (B)(6) THE ¿REPLACE GENERATOR SOON¿ MESSAGE WAS DISPLAYED ON THE PATIENT CONTROLLER INDICATING THE GENERATOR WAS APPROACHING ITS END OF SERVICE. THE IPG LOG WAS ASSESSED AND THE IPG WAS NOT AT A TRUE ERI, THE ELECTIVE REPLACEMENT INDICATOR MESSAGE DISPLAYED WAS PREMATURE. THE DEVICE HAS THE APPROPRIATE LEVEL OF BATTERY VOLTAGE TO PROVIDE THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7908121 ↗
• InjuryJul 4, 2018Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED ((B)(6)) THE PATIENT¿S IPG WOULD NOT COMMUNICATE WITH THE PATIENT PROGRAMMER OR CLINICIAN PROGRAMMER. MULTIPLE REPLACEMENT PROGRAMMERS WERE TRIED TO NO AVAIL. THE PHYSICIAN DECIDED TO REPLACE THE IPG WITH A NEW ONE IN (B)(6) 2018 (EXACT DATE UNKNOWN).

  Patient problems: Inadequate Pain Relief

  MAUDE report 7662341 ↗

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-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-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-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-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