Eon Mini™ 3788 (UDI 05415067019554)Recalls & reported problems

Summary

The FDA's MAUDE database contains 191 adverse event reports that list this exact device (DI 05415067019554), received between Jun 22, 2018 and Apr 20, 2026 — classified as 191 injuries.

The most frequently reported specific device problem is “Wireless Communication Problem” (69 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 191 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Wireless Communication Problem

  IT WAS REPORTED THE PATIENT¿S IPG HAD AN INCREASED RECHARGE BURDEN. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24932084 ↗
• InjuryDec 11, 2025Wireless Communication Problem; Wireless 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 WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE IPG WAS REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23780051 ↗
• InjuryDec 9, 2025Wireless Communication Problem; Wireless 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 23760487 ↗
• InjuryDec 5, 2025No Apparent Adverse Event; Wireless Communication Problem; No Apparent Adverse Event; Wireless Communication Problem

  THE IPG MEETS OR EXCEEDS 75% OF ITS EXPECTED LONGEVITY. THERE IS NO DEVICE MALFUNCTION; THEREFORE, THIS DEVICE IS NO LONGER CONSIDERED REPORTABLE.

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

  MAUDE report 23735018 ↗
• InjurySep 2, 2025Improper or Incorrect Procedure or Method; Improper 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 ON (B)(6) 2025 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22946408 ↗
• InjuryJul 21, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENTS IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 22561736 ↗
• InjuryJun 18, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED PATIENT'S IPG LOST COMMUNICATION WITH ALL EXTERNAL DEVICES. A MANUFACTURER REPRESENTATIVE CONFIRMED THE IPG WAS INOPERABLE. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 22288548 ↗
• InjuryJun 1, 2025Improper or Incorrect Procedure or Method; Improper 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. SURGICAL INTERVENTION WAS UNDERTAKEN (B)(6) 2025 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22121362 ↗
• InjuryMay 12, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  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) 2025 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 22005504 ↗
• InjuryNov 14, 2024Premature Discharge of Battery; Wireless Communication Problem; Premature Discharge of Battery; Wireless Communication Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD RECHARGE BURDEN ISSUES WITH THEIR IPG AS IT DID NOT PROVIDE THERAPY FOR 24 HOURS. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20692092 ↗
• InjuryJul 19, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PATIENT LOST THERAPY DUE TO NOT CHARGING THEIR IPG. THE IPG WAS CONFIRMED TO BE INOPERABLE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19781920 ↗
• InjuryJul 3, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENTS IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19666602 ↗
• InjuryJul 3, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS NOT ABLE TO CONNECT TO EXTERNAL DEVICES. UPON FURTHER INVESTIGATION THE PATIENT DOES NOT HAVE ANY OF THEIR CHARGING OR CONTROLLING EQUIPMENT, THEREFOR THE PATIENT DID NOT RECHARGE THE IPG AS RECOMMENDED IN YEARS. IN TURN, THE IPG BECAME INOPERABLE, AND PATIENT LOST THERAPY. SURGICAL INTERVENTION MAY TAKE PLACE AT A FUTURE DATE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19664506 ↗
• InjuryJun 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENTS IPG WAS EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 19630610 ↗
• InjuryMay 1, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT DID NOT CHARGE THEIR IPGS AS RECOMMENDED DUE TO A STROKE WHICH CAUSED THE IPGS TO BECOME INOPERABLE. NEXT COURSE OF ACTION IS UNDETERMINED AT THIS TIME.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19222190 ↗
• InjuryMar 25, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THE PATIENT¿S IPG HAD AN INCREASED RECHARGE BURDEN. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967131 ↗
• InjuryMar 23, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2024 WHERE THE IPG WAS REPLACED AND THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18965690 ↗
• InjuryFeb 23, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THE PATIENT HAD THEIR SCS IPG REPLACED BECAUSE THE IPG WAS INOPERABLE. SURGICAL INTERVENTION TOOK PLACE WHERE THE IPG WAS REPLACED, AND THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18773561 ↗
• InjuryFeb 21, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PATIENT LOST THERAPY DUE TO NOT CHARGING THE IPG. THE IPG WAS DEEMED INOPERABLE. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18754843 ↗
• InjuryFeb 5, 2024Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S HAD THEIR SYSTEM EXPLANTED FOR AN UNKNOWN REASON AT AN UNKNOWN DATE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18647382 ↗
• InjuryJan 30, 2024Wireless Communication Problem; Wireless Communication Problem

  ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2024 WHEREIN THE PATIENT'S IPG WAS EXPLANTED, REPLACED, AND THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18610593 ↗
• InjuryJan 15, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE IPG FAILED TO ESTABLISH COMMUNICATION WITH EXTERNAL DEVICES. THE IPG WAS DEEMED INOPERABLE, AND PATIENT LOST THERAPY. SURGICAL INTERVENTION MAY TAKE PLACE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18513203 ↗
• InjuryDec 21, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S IPG WAS EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. NO FURTHER INFORMATION KNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 18370705 ↗
• InjuryDec 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENTS SYSTEM WAS EXPLANTED ON AN UNKNOWN DATE DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18369264 ↗
• InjuryDec 15, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PATIENT HAD A STROKE AND DID NOT RECHARGE THE IPG AS RECOMMENDED. IN TURN, THE IPG BECAME INOPERABLE, AND PATIENT LOST THERAPY. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18335899 ↗

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-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-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-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-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-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-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