Eon Mini™ 3721Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05414734402620), received between Jun 26, 2018 and Jun 2, 2025 — classified as 13 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (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. 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.

• InjuryJun 2, 2025High impedance; High impedance

  IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON L1 AND L4-L5 LEADS. AS A RESULT, SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22128083 ↗
• InjuryOct 12, 2022Temperature Problem; Temperature Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-05637. IT WAS REPORTED THE PATIENT EXPERIENCED POCKET HEATING WHILE RECHARGING THEREFORE HAS STOPPED CHARGING. AS A RESULT, A NEW CHARGER MAY BE GIVEN TO THE PATIENT TO ADDRESS THE ISSUE. ON 08/01/2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PATIENTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PATIENTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED.

  Patient problems: Burning Sensation

  MAUDE report 15592206 ↗
• InjuryMay 3, 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 ISSUE WAS RESOLVED THROUGH AN IPG REPLACEMENT. EFFECTIVE THERAPY RESTORED POST-OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 14266101 ↗
• InjuryJul 12, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT DID NOT CHARGE AND MAINTAIN THE DEVICE AS RECOMMENDED, AND THE IPG BECAME INOPERABLE. AS A RESULT, SURGERY OCCURRED IN WHICH THE IPG WAS EXPLANTED AND REPLACED, WHICH RESOLVED THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12148457 ↗
• InjuryFeb 9, 2021Temperature Problem; Temperature Problem

  RELATED MFR REPORT: 1627487-2021-01120. IT WAS REPORTED THE PATIENT COMPLAINED OF HEATING DURING RECHARGE OF THE SCS SYSTEM IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT STATED THE CHARGER ANTENNA HEATED UP NOT ALLOWING IT TO BE PLACED ON THE SKIN. THE NEXT COURSE OF ACTION HAS NOT BEEN DETERMINED.

  Patient problems: Burning Sensation

  MAUDE report 11304990 ↗
• InjuryJan 19, 2021Temperature Problem; Temperature Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-00397. IT WAS REPORTED THE PATIENT EXPERIENCED POCKETING HEATING WHILE CHARGING. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: Burning Sensation

  MAUDE report 11195844 ↗
• InjuryDec 1, 2020Temperature Problem; Temperature Problem

  ADDITIONAL INFORMATION INDICATES SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2021 WHEREIN THE IPG WAS EXPLANTED AND REPLACED. ISSUE RESOLVED.

  Patient problems: Burning Sensation

  MAUDE report 10928244 ↗
• InjuryOct 12, 2020Temperature Problem; Temperature Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-32201. IT WAS REPORTED THAT PATIENT EXPERIENCED IPG POCKET HEATING WHILE CHARGING IPG. AS A RESULT, SURGERY OCCURRED DURING WHICH THE IPG WAS EXPLANTED. THE DATE OF EXPLANT IS UNKNOWN.

  Patient problems: Burning Sensation

  MAUDE report 10668162 ↗
• InjuryAug 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT LOST THERAPY AS THE IPG REACHED END OF SERVICE (EOS). IT IS UNKNOWN IF THE IPG DEPLETED PREMATURELY. IN TURN, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10364726 ↗
• InjuryJun 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER:1627487-2020-21599. IT WAS REPORTED THAT THE PATIENT STOPPED CHARGING THEIR DEVICE DUE TO POCKET HEATING INVOLVING A HIGH ENERGY CHARGING SYSTEM.

  Patient problems: Burning Sensation

  MAUDE report 10150634 ↗
• InjuryMay 15, 2020Temperature Problem; Temperature Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-04651. IT WAS REPORTED THE PATIENT EXPERIENCED POCKET HEATING WHILE CHARGING THEIR IPG. SURGICAL INTERVENTION TOOK PLACE WHERE THE SCS SYSTEM WAS EXPLANTED AT AN UNKNOWN DATE TO ADDRESS THE ISSUE.

  Patient problems: Burning Sensation

  MAUDE report 10060919 ↗
• MalfunctionApr 17, 2020Temperature Problem; Temperature Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-03556. IT WAS REPORTED THE PATIENT EXPERIENCED POCKET HEATING WHILE CHARGING THE IPG. AS A RESULT, THE IPG WAS EXPLANTED. THE DATE OF EXPLANT IS UNKNOWN. THE SYSTEM WAS ALSO EXPLANTED DUE TO INEFFECTIVE STIMULATION AS DOCUMENTED IN RELATED MANUFACTURER REFERENCE NUMBERS 1627487-2020-03665 AND 1627487-2020-03666.

  Patient problems: Discomfort

  MAUDE report 9975561 ↗
• InjuryFeb 19, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN IPG RECHARGE BURDEN. AS A RESULT, SURGICAL INTERVENTION OCCURRED IN WHICH THE IPG WAS EXPLANTED AND REPLACED, WHICH RESOLVED THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9729219 ↗
• MalfunctionFeb 13, 2020Temperature Problem; Temperature Problem

  RELATED MANUFACTURER REPORT: 1627487-2020-01462. IT WAS REPORTED THAT PATIENT EXPERIENCED POCKET HEATING WHILE THE SYSTEM IS RECHARGING. AS A RESULT THE CHARGING SYSTEM WAS EXCHANGED. PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9708127 ↗
• MalfunctionSep 11, 2019Temperature Problem; Temperature Problem

  REFERENCE MFR. REPORT#: 1627487-2019-10347. IT WAS REPORTED THAT THE PATIENT¿S IPG IS WARMING UP WHILE IT IS RECHARGING. ON 01 AUGUST 2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PATIENTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PATIENTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED.

  Patient problems: Burning Sensation

  MAUDE report 9000766 ↗
• InjuryJun 26, 2018Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THE IPG WAS INOPERABLE DUE TO NOT CHARGING. AS A RESULT, THE IPG WAS REPLACED AND THERAPY WAS RESTORED POST-OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 7638434 ↗

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-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-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-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-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-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-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-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-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