Eon Mini™ 3788 (UDI 05415067017307)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05415067017307), received between Oct 4, 2018 and Aug 13, 2024 — classified as 14 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THE PATIENT¿S IPG HAD AN INCREASED RECHARGE BURDEN. AS SUCH, SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19975731 ↗
• InjuryJul 18, 2024Improper 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) 2024 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19779626 ↗
• InjuryJul 18, 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 19771991 ↗
• InjuryJun 28, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG WAS HAVING DIFFICULTY CONNECTING WITH THEIR PROGRAMMER. AS A RESULT, THE PATIENT MAY UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19634686 ↗
• InjuryJun 27, 2024Improper 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) 2024 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19630725 ↗
• InjuryJan 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Insufficient Information

  MAUDE report 18574991 ↗
• InjuryDec 5, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PATIENT LOST THERAPY DUE TO NOT CHARGING THE IPG. AS SUCH, THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 18270617 ↗
• InjuryNov 17, 2022Battery 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 15821812 ↗
• InjuryNov 15, 2022No Apparent Adverse Event; Wireless Communication Problem; No Apparent Adverse Event; Wireless Communication Problem

  IT WAS REPORTED THE PATIENT¿S IPG LOST COMMUNICATION WITH EXTERNAL DEVICES. IN TURN, THE IPG WAS DEEMED INOPERABLE. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

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

  MAUDE report 15797393 ↗
• InjuryNov 15, 2022Improper or Incorrect Procedure or Method; Wireless Communication Problem; Improper or Incorrect Procedure or Method; Wireless Communication Problem

  IT WAS REPORTED THE PATIENT DID NOT RECHARGE THE IPG AS INSTRUCTED. AS SUCH, THE IPG BECAME INOPERABLE. IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE DEVICE WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15797219 ↗
• InjuryFeb 23, 2022Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THE PATIENTS SYSTEM IS AUTO REDUCING. SURGICAL INTERVENTION MAY BE PENDING TO REPLACE THE IPG IN ORDER TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13589129 ↗
• InjuryJan 6, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT LOST THERAPY DUE TO IPG BEING INOPERABLE FOR YEARS. PATIENT STOPPED CHARGING THE IPG FOR AN EXTENDED PERIOD OF TIME RENDING THE IPG INOPERABLE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2021 WHEREIN THE IPG WAS EXPLANTED AND REPLACED WITH A NEW IPG ADDRESSING THE ISSUE. REPORTEDLY, THERAPY WAS CONFIRMED POST OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13182790 ↗
• InjuryJul 16, 2021Temperature Problem; Temperature Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES THE PHYSICIAN CHANGED THE POSITION OF THE POCKET AND THE HEATING HAS RESOLVED.

  Patient problems: Burning Sensation

  MAUDE report 12185687 ↗
• InjuryJul 1, 2020High impedance; High impedance

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-21620, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-22408. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. DIAGNOSTICS INDICATED HIGH IMPEDANCE READINGS ON TWO CONTACTS . REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2020 WHEREIN THE PATIENT'S IPG AND EXTENSION WERE EXPLANTED. A NEW IPG WAS IMPLANTED TO ADDRESS THE ISSUE AND ACHIEVE NEW TECHNOLOGY. NO INTERVENTION WAS TAKEN ON THE LEAD. POST OPERATIVELY, THE LEAD CONTINUED TO SHOW HIGH IMPEDANCE ON 2 CONTACTS. HOWEVER, THE PATIENT WAS PROGRAMMED AND THERAPY COVERS THE PAIN AREA RESOLVING THE ISSUE

  Patient problems: Inadequate Pain Relief

  MAUDE report 10222310 ↗
• MalfunctionOct 25, 2019Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THE PATIENTS IPG BECAME INOPERABLE AND CON NOT COMMUNICATE WITH EXTERNAL DEVICES. THE NEXT COURSE OF ACTION IS UNDETERMINED AT THIS TIME.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9240857 ↗
• MalfunctionOct 4, 2018Communication or Transmission Problem; Communication or Transmission Problem

  FOLLOW-UP IDENTIFIED REPLACEMENT OF THE IPG RESOLVED THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 7934844 ↗

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-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-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-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-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-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