Eon Mini™ 3720Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05414734405324), received between Feb 5, 2020 and Sep 23, 2022 — classified as 9 injuries.

The most frequently reported specific device problem is “Wireless Communication Problem” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2022Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT LOST THERAPY DUE TO IPG BEING INOPERABLE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE 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 15469648 ↗
• InjuryJun 29, 2022Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT LOST THERAPY DUE TO IPG BEING INOPERABLE. AS SUCH. SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2022 WHEREIN THE IPG WAS EXPLANTED AND REPLACED WITH A NEW IPG ADDRESSING THE ISSUE. REPORTEDLY, THERAPY WAS CONFIRMED POST OP.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 14857127 ↗
• InjuryMay 19, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT DID NOT RECHARGE AS RECOMMENDED. IN TURN, THE 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 14444049 ↗
• InjuryAug 1, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE IPG WAS EXPLANTED AND REPLACED WITH A NON-RECHARGEABLE IPG. POST-OPERATIVELY, STIMULATION THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12257278 ↗
• InjuryOct 12, 2020Wireless Communication Problem; Wireless Communication Problem

  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 TO EXPLANT AND REPLACE THE DEVICE, WHICH RESOLVED THE ISSUE. THERAPY WAS RESTORED POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10668300 ↗
• InjuryAug 5, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2020-23509, 1627487-2020-23510. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGERY MAY OCCUR TO ADDRESS THE ISSUE. PAIN AT THE IPG SITE IS DOCUMENTED IN THE FOLLOWING REPORT (MANUFACTURER REFERENCE NUMBER: 1627487-2020-23376).

  Patient problems: Inadequate Pain Relief

  MAUDE report 10367044 ↗
• InjuryAug 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL REPORTING WAS RECEIVED THAT SURGERY OCCURRED TO EXPLANT THE IPG, WHICH ADDRESSED THE ISSUE.

  Patient problems: Pain

  MAUDE report 10354091 ↗
• InjuryApr 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED ON AN UNKNOWN DATE DUE TO UNKNOWN CIRCUMSTANCES.

  Patient problems: Death

  MAUDE report 9974817 ↗
• InjuryFeb 5, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THE PATIENT WAS EXPERIENCING AN INCREASE IN RECHARGE BURDEN. IN TURN, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9673429 ↗

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-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-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-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-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-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