Proclaim™ 3667Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05415067023254), received between Nov 26, 2018 and Oct 20, 2020 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (3 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-2363-2024 · Root cause: Vendor change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 20, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) WOULD BE REPLACED DUE TO A BROKEN IPG HEADER PORT PLUG. SURGICAL INTERVENTION PLANNED, BUT NOT YET SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10708649 ↗
• InjuryOct 1, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THE PATIENT'S SCS IPG WAS INTERFERED BY THE USE OF A MONOPOLAR KNIFE DURING A SURGERY. REPORTEDLY, AFTER THE SURGERY IT WAS IMPOSSIBLE TO COMMUNICATE WITH THE SCS IPG AND THE PATIENT CONTROLLER OR THE CLINICIAN PROGRAMMER. CONSEQUENTLY, SURGICAL INTERVENTION WAS TAKEN AND THE PATIENT'S SCS IPG WAS REPLACED WITH A NEW ONE AND STIMULATION THERAPY RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10617516 ↗
• InjuryFeb 13, 2020Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THE PATIENTS IPG BECAME INOPERABLE FOLLOWING AN UNRELATED SURGERY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE IPG WAS EXPLANTED AND REPLACED. SURGICAL INTERVENTION ADDRESSED THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9705964 ↗
• MalfunctionAug 7, 2019Use of Device Problem; Device Damaged by Another Device; Use of Device Problem; Device Damaged by Another Device

  IT WAS REPORTED DURING THE PROCEDURE TO REVISE THE PATIENT'S SCS LEAD (REFERENCE MFR MDR(S) # 1627487-2019-08914 AND 1627487-2019-08915), THE SURGEON HAD TO REMOVE THE IPG OUT OF THE ABDOMEN. HOWEVER, WHEN THE SURGEON REMOVED THE IPG USING A KOCHER INSTRUMENT A HOLE WAS MADE IN THE BATTERY BY THE KOCHER INSTRUMENT. CONSEQUENTLY, THE PHYSICIAN HAD TO REPLACE THE IPG WITH A NEW ONE. NO ADVERSE PATIENT CONSEQUENCES OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8872374 ↗
• InjuryJun 10, 2019No Device Output; No Device Output

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPY DUE TO THEIR IPG BECOMING INOPERABLE. AS A RESULT, SURGICAL INTERVENTION WAS TAKEN TO REPLACE THE DEVICE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8683269 ↗
• InjuryMay 24, 2019No Device Output; No Device Output

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPY DUE TO THEIR IPG BECOMING INOPERABLE. AS A RESULT, SURGICAL INTERVENTION WAS TAKEN TO REPLACE THE IPG. THE ISSUE HAS BEEN ADDRESSED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8641100 ↗
• InjuryMar 15, 2019Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THE PATIENT¿S IPG WOULD NOT COMMUNICATE. PATIENT UNDERWENT SURGICAL INTERVENTION FOR UNKNOWN REASONS, PRIOR TO THE IPG BEING RENDERED INOPERABLE, WHEREIN ELECTROCAUTERY WAS USED. THE IPG WAS PLACED IN SURGERY MODE. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2019 WHEREIN THE IPG WAS EXPLANTED AND REPLACED WITH A NEW IPG. REPORTEDLY, THERAPY WAS RESTORED POSTOPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8424967 ↗
• InjuryNov 26, 2018Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  THIS REPORT IS RELATED TO A BELGIUM PATIENT. IT WAS REPORTED THE PATIENT'S IPG BECAME INOPERABLE AFTER COMING IN CONTACT WITH BIPOLAR ELECTROCAUTERY. AS A RESULT, THE PATIENT MAY UNDERGO SURGICAL INTERVENTION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8104191 ↗

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-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-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-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-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-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