Eon Mini™ 3722Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05414734405300), received between Dec 3, 2018 and Oct 14, 2022 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Wireless Communication Problem” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryOct 14, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF THERAPY. TROUBLESHOOTING REVEALED HIGH IMPEDANCE ON ONE LEAD. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2022 WHEREIN THE LEAD WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD HAD HIGH IMPEDANCE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15607649 ↗
• MalfunctionFeb 17, 2022Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THE PATIENT'S CHARGER WAS SMOKING AND HAD A BURNING SMELL. IN TURN, THE NURSE GAVE THE PATIENT A NEW CHARGER, RESOLVING THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13552334 ↗
• InjuryNov 19, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PATIENT DID NOT RECHARGE THE IPG AS RECOMMENDED. AS SUCH, THE IPG BECAME INOPERABLE. SURGICAL INTERVENTION IS PLANNED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12847618 ↗
• InjurySep 10, 2021Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE IPG FAILED TO ESTABLISH COMMUNICATION WITH EXTERNAL DEVICES. THE IPG WAS DEEMED INOPERABLE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12455906 ↗
• InjuryJul 13, 2021Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT DURING AN INTRAOPERATIVE TESTING DIAGNOSTIC REVEALED HIGH IMPEDANCE. AS SUCH, THE LEAD WAS EXPLANTED AND REPLACED WITH A NEW LEAD TO ADDRESS THE ISSUE. IT WAS NOTED THAT THE LEAD HAD BREAKAGE. REPORTEDLY, THERAPY WAS CONFIRMED POST OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12162031 ↗
• InjuryJul 6, 2021Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THE PATIENT HAD HIS SCS IPG REPLACED BECAUSE THE IPG WAS INOPERABLE. STIMULATION THERAPY WAS REPORTEDLY RESTORED POSTOPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12125208 ↗
• InjuryMar 29, 2021High impedance; High impedance

  IT WAS REPORTED PATIENT WAS EXPERIENCING INEFFECTIVE THERAPY DUE TO HIGH IMPEDANCE. AS A RESULT TO ADDRESS THE ISSUE PATIENT MAY BE AWAITING SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11582303 ↗
• InjuryDec 16, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-48918; RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2020-48920. IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY. REPORTEDLY, PATIENT HAD A FALL AFTER THE IMPLANT. ATTEMPTS TO REPROGRAM WERE UNSUCCESSFUL. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE LEADS AND IPG WERE EXPLANTED AND REPLACED WITH A COMPETITOR¿S SYSTEM.

  Patient problems: Inadequate Pain Relief

  MAUDE report 11024703 ↗
• InjurySep 1, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE IPG BECAME INOPERABLE. AS A RESULT, SURGERY OCCURRED TO EXPLANT AND REPLACE THE IPG, WHICH RESOLVED THE ISSUE. THERAPY WAS RESTORED POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10480685 ↗
• InjuryMay 6, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THE PATIENT'S IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES AND WAS DEEMED INOPERABLE. AS A RESULT, THE PATIENT UNDERWENT SURGERY WHEREIN THE IPG WAS EXPLANTED AND REPLACED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10029939 ↗
• InjuryFeb 12, 2020Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THE PATIENT¿S IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. A MANUFACTURER REPRESENTATIVE CONFIRMED THE ISSUE AND THE IPG DEEMED INOPERABLE. SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE IPG WAS EXPLANTED AND REPLACED, RESTORING THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9699751 ↗
• InjuryDec 3, 2018Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE CHARGER DOES NOT LOCATE THE IPG. THE PATIENT DOES NOT RECALL THE LAST TIME THE IPG WAS CHARGED. IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE IPG WAS EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST-OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8126495 ↗

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-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-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-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-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