Eon C™ 3688 (UDI 05415067017369)Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 05415067017369), received between Oct 25, 2018 and Sep 14, 2023 — classified as 34 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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 36 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2023Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG BECAME INOPERABLE. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE IPG WAS EXPLANTED AND REPLACED WITH NO COMPLICATIONS.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17752870 ↗
• InjuryJun 6, 2022Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG BECAME INOPERABLE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14602005 ↗
• InjuryMay 31, 2022Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG HAD BECOME INOPERABLE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14551699 ↗
• InjuryMay 14, 2022Improper 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 PATIENT HAS NOT RECHARGED OR USED THE IPG IN OVER A YEAR. THE ISSUE WAS RESOLVED THROUGH AN IPG REPLACEMENT. EFFECTIVE THERAPY RESTORED POST-OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14403466 ↗
• InjurySep 30, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT PATIENT LOST THERAPY AS THE IPG REACHED END OF SERVICE (EOS). IT IS UNKNOWN IF THE IPG DEPLETED PREMATURELY. SURGERY MAY OCCUR TO ADDRESS THE ISSUE

  Patient problems: Inadequate Pain Relief

  MAUDE report 12557599 ↗
• InjuryJul 30, 2021Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT PATIENT EXPERIENCED SHOCKING SENSATION AT THE IPG SITE. AS A RESULT, THE IPG WAS EXPLANTED ADDRESSING THE ISSUE.

  Patient problems: Shock

  MAUDE report 12253246 ↗
• InjuryJul 20, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG WAS INOPERABLE. AS A RESULT, THE PHYSICIAN EXPLANTED AND REPLACED THE IPG. SURGICAL INTERVENTION RESOLVED THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12199484 ↗
• MalfunctionJun 17, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG WAS INOPERABLE. IT IS UNKNOWN IF THE IPG HAS DEPLETED PREMATURELY OR NOT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12021598 ↗
• InjuryApr 2, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THE PATIENT'S IPG FAILED TO ESTABLISH COMMUNICATION WITH EXTERNAL DEVICES. A MANUFACTURER REPRESENTATIVE CONFIRMED THE ISSUE AND THE IPG WAS DEEMED INOPERABLE. IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11607531 ↗
• InjuryMar 12, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THE PATIENT'S IPG HAS REACHED ITS END OF SERVICE. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11475098 ↗
• InjuryNov 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  RELATED MANUFACTURER REPORT NUMBERS 1627487-2020-33306, 1627487-2020-33307. IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS EXPLANTED AND REPLACED WITH A COMPETITOR SYSTEM ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. FURTHER INFORMATION IS CURRENTLY UNAVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10788060 ↗
• InjuryOct 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION, INDICATES THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10743832 ↗
• InjurySep 23, 2020Therapeutic or Diagnostic Output Failure; Insufficient Device Problem Information; Therapeutic or Diagnostic Output Failure; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT¿S IPG BECAME INOPERABLE AROUND (B)(6) 2019. TO ADDRESS THE ISSUE, THE PHYSICIAN EXPLANTED THE IPG AND REPLACED IT WITH A NEW MODEL, WHICH RESOLVED THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10574487 ↗
• InjurySep 15, 2020Improper or Incorrect Procedure or Method; Wireless Communication Problem; Improper or Incorrect Procedure or Method; Wireless Communication Problem

  IT WAS REPORTED THE PATIENT'S IPG IS INOPERABLE. IT WAS STATED THE PATIENT DID NOT RECHARGE THE IPG AS RECOMMENDED. THE PATIENT ALSO REPORTED MULTIPLE FALLS. THE PATIENT MAY UNDERGO SURGICAL INTERVENTION AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Fall; Inadequate Pain Relief

  MAUDE report 10537150 ↗
• MalfunctionJul 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE IPG WAS EXPLANTED AND REPLACED ON (B)(6) 2020. THE PATIENT HAS EFFECTIVE THERAPY POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10338763 ↗
• InjuryJul 6, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2020-22480, 1627487-2020-22481. IT WAS REPORTED THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG WAS EXPLANTED AND REPLACED, CURRENT LEADS WERE DISCONNECTED AND TWO NEW LEADS WERE ADDED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10236929 ↗
• InjuryJun 25, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT PATIENT LOST STIMULATION. A MANUFACTURER REPRESENTATIVE MET WITH PATIENT AND THE IPG WAS DEEMED INOPERABLE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2020, WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10197851 ↗
• InjuryJun 10, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REPORT: 1627487-2020-21555, RELATED MANUFACTURER REPORT: 1627487-2020-21556, RELATED MANUFACTURER REPORT: 1627487-2020-21557, RELATED MANUFACTURER REPORT: 1627487-2020-21558, RELATED MANUFACTURER REPORT: 1627487-2020-21559, RELATED MANUFACTURER REPORT: 1627487-2020-21560. IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE STIMULATION. PATIENT DENIES ANY TRAUMAS OR FALLS. PROGRAMMING CHANGES HAVE BEEN ATTEMPTED PRIOR HOWEVER WAS UNSUCCESSFUL. DEVICE SYSTEM WAS EXPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10140959 ↗
• InjuryJun 4, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THE PATIENT STATED THE LAST TIME SHE HAD EFFECTIVE THERAPY WAS IN 2018. PATIENT INDICATED SHE STOPPED USING THE DEVICE IN 2018, AND IT WAS EXPLANTED IN APPROXIMATELY (B)(6) 2020 (PATIENT UNABLE TO RECALL EXACT DATE).

  Patient problems: Inadequate Pain Relief

  MAUDE report 10118555 ↗
• InjuryMay 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A LOW BATTERY MESSAGE FOR PATIENT'S IPG DISPLAYED ON EXTERNAL DEVICES. A MANUFACTURER REPRESENTATIVE CONFIRMED THE ISSUE AND THE IPG WAS DEEMED INOPERABLE. IN TURN, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10077611 ↗
• InjuryApr 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INOPERABLE IPG. THE PATIENT LAST HAD EFFECTIVE THERAPY AND WAS LAST ABLE TO SUCCESSFULLY CHARGE APPROXIMATELY TWO YEARS AGO. SURGERY MAY BE PENDING TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10016235 ↗
• InjuryMar 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE LOST THERAPY AROUND 2 MONTHS AGO DUE TO IPG BEING INOPERABLE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2020 WHEREIN THE IPG WAS EXPLANTED AND REPLACED WITH A NEW IPG. THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9865026 ↗
• InjuryMar 22, 2020Insufficient Device Problem Information; Wireless Communication Problem; Insufficient Device Problem Information; Wireless Communication Problem

  IT WAS REPORTED THE PATIENT'S IPG WAS INOPERABLE AS IT WOULD NO LONGER COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, THE PATIENT'S IPG WAS EXPLANTED AND REPLACED. SURGICAL INTERVENTION RESOLVED THE PATIENT'S ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9863895 ↗
• InjuryFeb 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE SCS IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9734904 ↗
• InjuryDec 9, 2019Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THE PATIENT LOST THERAPY DUE TO THE IPG BECOMING INOPERABLE. IN TURN, THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9440422 ↗

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-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-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-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-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