Eon C™ 3688 (UDI 05414734402460)Recalls & reported problems

Summary

The FDA's MAUDE database contains 349 adverse event reports that list this exact device (DI 05414734402460), received between May 31, 2018 and Jun 10, 2026 — classified as 2 deaths, 336 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (76 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 349 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2026Insufficient 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 25461931 ↗
• InjuryNov 20, 2025Premature Discharge of Battery; Premature 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 AN UNKNOWN DATE WHEREIN THE IPG WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23612657 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG SITE FOLLOWING WEIGHT LOSS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE SYSTEM WAS EXPLANTED.

  Patient problems: Implant Pain

  MAUDE report 22311386 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG SITE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain

  MAUDE report 20186029 ↗
• InjuryAug 7, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG WAS DEPLETED AND WOULD NOT CHARGE. 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 19925488 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INFECTION WAS PRESENT AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN IN 2013 WHEREIN THE SYSTEM WAS EXPLANTED, AND PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS TO ADDRESS THE ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 19461178 ↗
• InjuryMay 22, 2024Battery Problem; Wireless Communication Problem; Battery Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT'S RECHARGEABLE IPG WAS INOPERABLE. SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 19371767 ↗
• InjuryMar 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE IPG WAS EXPLANTED FOR AN UNKNOWN REASON. DATE OF EXPLANT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18862333 ↗
• InjuryAug 7, 2023Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG BECAME INOPERABLE. IT IS UNKNOWN IF THE DEVICE HAD PREMATURELY DEPLETED. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17476781 ↗
• InjuryJun 20, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG BECAME INOPERABLE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 IN WHICH THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 17162611 ↗
• InjuryJun 16, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG WAS INOPERABLE DUE TO A DEAD BATTERY. SURGICAL INTERVENTION TOOK PLACE WHERE THE IPG WAS EXPLANTED AND REPLACED. THERAPY RESTORED POST PROCEDURE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17143666 ↗
• InjuryJun 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS EXPLANTED AT A UNKNOWN DATE FOR A UNKNOWN REASON. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17075701 ↗
• InjuryMar 21, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG WAS AT END OF LIFE. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16583032 ↗
• InjuryFeb 16, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT PATIENTS IPG BECAME INOPERABLE. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16386195 ↗
• InjuryJan 4, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG HAD REACHED END OF LIFE. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16099521 ↗
• InjuryDec 28, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG IS REACHING END OF LIFE. SURGICAL INTERVENTION IS PENDING TO ADDRESS THIS ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16063833 ↗
• InjuryDec 23, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THE PATIENT¿S IPG APPROACHED END OF LIFE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2022 TO ADDRESS THE ISSUE. IPG WAS EXPLANTED AND REPLACED. STIMULATION THERAPY WAS REPORTEDLY RESTORED POSTOPERATIVELY

  Patient problems: Inadequate Pain Relief

  MAUDE report 16045608 ↗
• InjuryDec 23, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PATIENT LAST CHARGED THE IPG APPROXIMATELY A YEAR AGO. THE IPG WOULD NO LONGER COMMUNICATE WITH THE PATIENT PROGRAMMER AND CHARGER. SURGICAL INTERVENTION OCCURRED ON (B)(6) 2022 WHERE THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 16042606 ↗
• InjuryNov 17, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A EXPLANT FOR A UNKNOWN REASON. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15821717 ↗
• InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INFECTION WAS PRESENT AT THE IPG SITE. SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2022 AND IN WHICH THE PATIENT HAD THEIR IPG REVISED AND IRRIGATED. EFFECTIVE THERAPY WAS RESTORED.

  Patient problems: Discomfort; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 15762868 ↗
• InjuryOct 19, 2022Battery Problem; Wireless Communication Problem; Battery Problem; Wireless Communication Problem

  IT WAS REPORTED THE PATIENT¿S IPG WAS APPROACHING END OF LIFE. SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15635187 ↗
• InjuryOct 3, 2022Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THE PATIENT'S IPG REACHED END OF LIFE. AS A RESULT, SURGICAL INTERVENTION OCCURRED WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15534513 ↗
• InjurySep 27, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THE PATIENT'S IPG TURNED INOPERABLE AND THE PATIENT LOST THERAPY. IT IS UNKNOWN OF THE IPG DEPLETED PREMATURELY. SURGICAL INTERVENTION MAY OCCUR TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15492511 ↗
• InjurySep 27, 2022Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THE PATIENT'S IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES AND THE PATIENT LOST THERAPY. A MANUFACTURER REPRESENTATIVE CONFIRMED THE ISSUE. AS A RESULT, SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15491005 ↗
• MalfunctionSep 7, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THE IPG REACHED END OF LIFE. IT IS UNKNOWN IF THE IPG DEPLETED PREMATURELY. SURGERY TO REPLACE THE IPG MAY OCCUR IN THE FUTURE TO ADDRESS THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15369368 ↗

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-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-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-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-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