Prodigy MRI™ 3772Recalls & reported problems

Summary

The FDA's MAUDE database contains 3,162 adverse event reports that list this exact device (DI 05415067017093), received between Jun 11, 2018 and Sep 30, 2026 — classified as 2 deaths, 3,142 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Wireless Communication Problem” (1,034 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 3,162 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Improper or Incorrect Procedure or Method

  It was reported the patient did not recharge the IPG as recommended. As such, the IPG became inoperable. In turn, the patient underwent surgical intervention wherein the IPG was explanted and replaced. Effective therapy restored.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50944874 ↗
• InjurySep 29, 2026Premature Discharge of Battery

  It was reported that the patient experienced increase in recharge burden. As such, surgical intervention took place wherein the IPG was explanted and replaced to address the issue. Therapy was confirmed post op.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938705 ↗
• InjurySep 29, 2026Improper or Incorrect Procedure or Method

  It was reported that the patient did not charge their IPG as recommended and 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 50937106 ↗
• InjurySep 29, 2026Premature Discharge of Battery

  It was reported the patient¿s IPG had an increased recharge burden, and the patient experienced ineffective stimulation due to a fractured lead. X-rays confirmed the fracture. Surgical intervention took place wherein the patient¿s system was explanted and replaced to address the issue. Second lead was electively replaced. Effective stimulation was restored post-op.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932560 ↗
• InjurySep 28, 2026Wireless Communication Problem

  It was reported that the patient's IPG became unable to communicate with external devices. Troubleshooting has been unable to resolve the issue. As a result, surgical intervention may be undertaken in the future.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916907 ↗
• InjurySep 28, 2026Wireless Communication Problem

  It was reported that the patient's 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 50916626 ↗
• InjurySep 28, 2026Wireless Communication Problem

  It was reported the IPG would not communicate with external devices. Surgical intervention may take place to replace the IPG.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50910692 ↗
• InjurySep 28, 2026Wireless Communication Problem

  It was reported that the patient's IPG was inoperable. Surgical intervention took place where the IPG was replaced.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50910689 ↗
• InjurySep 25, 2026Wireless Communication Problem

  It was reported the patient's IPG was inoperable and patient needs MRIs. In turn, surgical intervention was undertaken during which the IPG was explanted and replaced. Effective therapy was confirmed.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50895954 ↗
• InjurySep 24, 2026Improper or Incorrect Procedure or Method

  It was reported that the patient did not charge their IPG as recommended and 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 50888551 ↗
• InjurySep 23, 2026Improper or Incorrect Procedure or Method

  Patient problems: Inadequate Pain Relief

  MAUDE report 50874737 ↗
• InjurySep 23, 2026Improper or Incorrect Procedure or Method

  It was reported that the patient did not charge their IPG as recommended and 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 50871406 ↗
• InjurySep 23, 2026Wireless Communication Problem

  It was reported that the patient's IPG became unable to communicate with external devices. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the IPG was explanted and replaced to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50868099 ↗
• InjurySep 22, 2026Wireless Communication Problem

  It was reported the patient¿s IPG was unable to communicate with external devices. Surgical intervention was undertaken wherein the patient's IPG was explanted and replaced. Therapy was restored.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50860152 ↗
• InjurySep 22, 2026Improper or Incorrect Procedure or Method

  It was reported that the patient did not charge their IPG as recommended and 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 50859873 ↗
• InjurySep 22, 2026Improper or Incorrect Procedure or Method

  It was reported that the patient did not charge their IPG as recommended and the IPG became unable to communicate with external devices. As a result, surgical intervention may be taken at a later date.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50858225 ↗
• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50848206 ↗
• InjurySep 18, 2026Wireless Communication Problem

  Patient problems: Inadequate Pain Relief

  MAUDE report 50829356 ↗
• InjurySep 18, 2026Wireless Communication Problem

  It was reported the patient's IPG is inoperable. Surgical intervention may take place at a later date.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50819462 ↗
• InjurySep 18, 2026Wireless Communication Problem

  It was reported that patients 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 50817341 ↗
• InjurySep 16, 2026Premature Discharge of Battery

  It was reported that the patient experienced recharge burden and ineffective therapy. Reprogramming 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 50793675 ↗
• InjurySep 16, 2026Wireless Communication Problem

  It was reported that the patient's IPG became unable to communicate with external devices. Troubleshooting has been unable to resolve the issue. It was also reported that patient experienced ineffective therapy. X-ray imaging revealed migration of both leads. As a result, surgical intervention was undertaken wherein IPG and leads were replaced to address the issue.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50792380 ↗
• InjurySep 15, 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 was undertaken wherein the IPG was explanted and replaced o address the issue. Therapy restored post-op.

  Patient problems: Inadequate Pain Relief

  MAUDE report 50777899 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Implant Pain

  MAUDE report 50766046 ↗
• InjurySep 14, 2026Improper or Incorrect Procedure or Method

  Patient problems: Inadequate Pain Relief

  MAUDE report 50764612 ↗

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-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-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-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