Proclaim™ 3670Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,253 adverse event reports that list this exact device (DI 05415067046383), received between Dec 22, 2022 and Sep 30, 2026 — classified as 2 deaths, 1,177 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (326 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. 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-2364-2024 · Root cause: Vendor change control · 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-2507-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,253 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that following weight loss, the patient experienced discomfort at the IPG site. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the IPG was replaced, and the pocket site was modified to address the issue.

  Patient problems: Implant Pain

  MAUDE report 50946088 ↗
• InjurySep 29, 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 was undertaken on (b)(6) 2026 wherein the IPG was repositioned to address the issue.

  Patient problems: Implant Pain

  MAUDE report 50936725 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient experienced an infection at the IPG site. As a result, surgical intervention was undertaken wherein the IPG was repositioned to address the issue. The patient was administered oral antibiotics to address the issue.

  Patient problems: Post Operative Wound Infection

  MAUDE report 50936474 ↗
• InjurySep 29, 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 IPG was explanted and replaced to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50933621 ↗
• InjurySep 29, 2026Wireless Communication Problem

  Patient problems: Inadequate Pain Relief

  MAUDE report 50932640 ↗
• InjurySep 29, 2026Wireless Communication Problem

  It was reported the patient¿s IPG was unable to communicate with external devices. A manufacturer representative confirmed the issue and the IPG deemed inoperable. Surgical intervention may be taken at a later date to address the issue.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932033 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50924576 ↗
• InjurySep 28, 2026Wireless Communication Problem

  Patient problems: Inadequate Pain Relief

  MAUDE report 50923999 ↗
• InjurySep 28, 2026Wireless Communication Problem

  Patient problems: Inadequate Pain Relief

  MAUDE report 50923979 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was experiencing pain at the IPG site following weight loss. In turn, surgical intervention was undertaken on (b)(6) 2026 wherein the IPG was moved up to address the issue.

  Patient problems: Implant Pain

  MAUDE report 50918919 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced reduced wound healing and erosion at the IPG site. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the system was explanted to address the issue.

  Patient problems: Erosion

  MAUDE report 50917922 ↗
• InjurySep 28, 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. 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 50913701 ↗
• MalfunctionSep 27, 2026Temperature Problem

  Patient problems: Burning Sensation

  MAUDE report 50910472 ↗
• InjurySep 25, 2026Insufficient Device Problem Information

  Patient problems: Inadequate Pain Relief

  MAUDE report 50903658 ↗
• InjurySep 25, 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 may be undertaken to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50899863 ↗
• InjurySep 25, 2026Premature Discharge of Battery

  Patient problems: Inadequate Pain Relief

  MAUDE report 50899853 ↗
• InjurySep 25, 2026Wireless Communication Problem

  It was reported the patient's IPG was inoperable. Surgical intervention may occur later to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50898835 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient experienced inadequate stimulation with their SCS system, pain at the IPG site and shocks when turning up the stimulation. As a result, surgical intervention was undertaken wherein the entire system was explanted.NOTE: It is unknown which lead is related to this issue.

  Patient problems: Implant Pain

  MAUDE report 50895948 ↗
• InjurySep 25, 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 was unable to resolve the issue. As a result, surgical intervention was undertaken on (b)(6) 2026 where in the IPG was explanted and replaced to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50893068 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Implant Pain

  MAUDE report 50892252 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Post Operative Wound Infection

  MAUDE report 50892169 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient underwent an implant procedure where in post-op, patient noted pain in their leg. Surgical intervention took place to explant system. Pain resolved post removal.

  Patient problems: Pain

  MAUDE report 50886416 ↗
• InjurySep 24, 2026Insufficient Device Problem Information

  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 50886302 ↗
• InjurySep 23, 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 may be undertaken to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50871750 ↗
• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient experienced an infection at an unknown site. As a result, surgical intervention was undertaken in (b)(6) 2026 wherein the entire system was explanted to address the issue.

  Patient problems: Post Operative Wound Infection

  MAUDE report 50859982 ↗

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-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-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-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-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-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