Proclaim™ 3660Recalls & reported problems

Summary

The FDA's MAUDE database contains 13,336 adverse event reports that list this exact device (DI 05415067031419), received between Nov 20, 2019 and Sep 30, 2026 — classified as 25 deaths, 12,562 injuries, 748 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (4,411 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-2358-2024 · 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-2505-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 13,336 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 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.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50951908 ↗
• InjurySep 30, 2026Wireless Communication Problem

  Patient problems: Inadequate Pain Relief

  MAUDE report 50951787 ↗
• MalfunctionSep 30, 2026Wireless Communication Problem

  It was reported the patient system was unable to disable MRI mode following an MRI. An Abbott representative met with the patient and was able to successfully disable the patient¿s IPG from MRI Mode using an Orion Exit Tool (OET). Once the IPG was taken out of MRI Mode, the patient controller and/or clinician programmer were able to bond with the IPG, and restored therapy.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50951052 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Implant Pain

  MAUDE report 50949377 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient experienced pain at the IPG site and ineffective therapy. As a result, surgical intervention may be undertaken to address the issue.

  Patient problems: Implant Pain

  MAUDE report 50949229 ↗
• InjurySep 30, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50948753 ↗
• InjurySep 29, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 50939805 ↗
• InjurySep 29, 2026Insufficient Device Problem Information

  It was reported that the patient's system was explanted. The reason for explant and date of explant is unknown.

  Patient problems: Insufficient Information

  MAUDE report 50938842 ↗
• InjurySep 29, 2026Insufficient Device Problem Information

  It was reported that the patient¿s system was explanted 4-5 years ago. Reason for explant and date of explant is unknown.

  Patient problems: Insufficient Information

  MAUDE report 50938821 ↗
• InjurySep 29, 2026Insufficient Device Problem Information

  It was reported patient underwent surgical intervention wherein the system was explanted due to an unknown issue.

  Patient problems: Insufficient Information

  MAUDE report 50938718 ↗
• 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 wherein the IPG was explanted and replaced to resolve the issue.

  Patient problems: Implant Pain

  MAUDE report 50937666 ↗
• 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. Therapy was restored post-operatively.

  Patient problems: Implant Pain

  MAUDE report 50937477 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient's IPG was protruding through the skin. Surgical intervention took place where the IPG was explanted.

  Patient problems: Pocket Erosion

  MAUDE report 50936282 ↗
• InjurySep 29, 2026Insufficient Device Problem Information

  It was reported that the patient's IPG was replaced for an unknown reason.

  Patient problems: Insufficient Information

  MAUDE report 50935699 ↗
• InjurySep 29, 2026No Apparent Adverse Event; Insufficient Device Problem Information

  It was reported that surgical intervention took place to replace the patient's IPG for an unknown reason.

  Patient problems: Inadequate Pain Relief; Insufficient Information

  MAUDE report 50935394 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Implant Pain

  MAUDE report 50935181 ↗
• InjurySep 29, 2026Insufficient Device Problem Information

  It was reported that the patient had their IPG explanted on (b)(6) 2026 for an unknown reason.

  Patient problems: Insufficient Information

  MAUDE report 50934332 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced an infection. As a result, surgical intervention took place wherein the SCS system was explanted to address the issue. Date of explant is estimated.

  Patient problems: Unspecified Infection

  MAUDE report 50932488 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Implant Pain

  MAUDE report 50926232 ↗
• InjurySep 28, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50924655 ↗
• InjurySep 28, 2026Migration

  Patient problems: Implant Pain

  MAUDE report 50924520 ↗
• InjurySep 28, 2026Wireless Communication Problem

  It was reported that, following multiple surgeries where the IPG was not set to surgery mode, the patient was unable to connect to their IPG. In turn, surgical intervention was undertaken wherein the IPG was explanted and replaced, resolving the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50919572 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced pain/discomfort at the IPG site as they felt the IPG was too close to their spine. 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 50917812 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that following weight loss, the patient experienced pain at the IPG site. As a result, surgical intervention was undertaken on 08SEP2026 wherein the IPG was explanted and replaced to address the issue.

  Patient problems: Implant Pain

  MAUDE report 50915176 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Implant Pain

  MAUDE report 50905501 ↗

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-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-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-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-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