Eon Mini™ 3788 (UDI 05414734402651)Recalls & reported problems
St. Jude Medical, Inc. · IPG, 16-Channel Rechargeable · Class 3 · Implant
All models of Eon Mini (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Eon Mini 3788 spinal cord stimulator is an implanted pulse generator used for pain relief. Its 4,667 adverse event reports mostly describe inadequate pain relief and wireless communication failures, and several describe a battery that was not charged, which in some cases led to surgery to remove the implant. The reports include 1 death and 4,641 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 4,666
- Deaths reported
- 1
- Injuries reported
- 4,640
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4,666 adverse event reports that list this exact device (DI 05414734402651), received between Apr 22, 2015 and Sep 28, 2026 — classified as 1 death, 4,640 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1,291 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.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1,291
- Wireless Communication Problem1,208
- Adverse Event Without Identified Device or Use Problem547
- Therapeutic or Diagnostic Output Failure456
- Insufficient Device Problem Information431
- Use of Device Problem384
- No Device Output207
- Premature Discharge of Battery158
Patient problems
- Inadequate Pain Relief3,638
- No Consequences Or Impact To Patient299
- No Known Impact Or Consequence To Patient152
- Insufficient Information148
- No Clinical Signs, Symptoms or Conditions120
- Pain108
- Failure of Implant99
- Discomfort72
Recent adverse event reports
The 25 most recent of 4,666 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Wireless Communication Problem
Patient problems: Inadequate Pain Relief
MAUDE report 50918943 ↗InjurySep 22, 2026Wireless Communication Problem
It was reported that the patient¿s IPG was inoperable. As such, surgical intervention took place wherein the IPG was explanted and replaced to address the issue. Therapy was restored post op.
Patient problems: Inadequate Pain Relief
MAUDE report 50858546 ↗InjurySep 22, 2026Insufficient Device Problem Information
It was reported that the patient had their system explanted on an unknown date for an unknown reason.
Patient problems: Insufficient Information
MAUDE report 50849898 ↗InjurySep 15, 2026Improper 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 may take place at a later date.
Patient problems: Inadequate Pain Relief
MAUDE report 50774232 ↗InjuryJul 27, 2026Improper or Incorrect Procedure or Method
It was reported patient's IPG became inoperable due to patient stopped charging the device. Surgical intervention was undertaken wherein the IPG was explanted and replaced to address the issue. Therapy was restored post-op.
Patient problems: Inadequate Pain Relief
MAUDE report 50011571 ↗InjuryJun 10, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION ON AN UNKNOWN DATE WHEREIN THE IPG WAS EXPLANTED FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 25461484 ↗InjuryMay 27, 2026Improper 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)2026 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25308857 ↗InjuryMay 22, 2026Improper 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 MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 25262880 ↗InjuryMay 20, 2026Insufficient 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 25233483 ↗InjuryMay 5, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD THEIR IPG EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 25086132 ↗InjuryMay 3, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD THEIR SYSTEM EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 25064259 ↗InjuryMar 30, 2026Wireless Communication Problem
IT WAS REPORTED PATIENT'S IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. A MANUFACTURER REPRESENTATIVE DEEMED THE IPG WAS INOPERABLE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN AT AN UNKNOWN TIME WHEREIN THE IPG WAS EXPLANTED.
Patient problems: Inadequate Pain Relief
MAUDE report 24718697 ↗InjuryMar 30, 2026Improper 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. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24717007 ↗InjuryMar 19, 2026Insufficient Device Problem Information
IT WAS REPORTED THE PATIENT'S IPG WAS EXPLANTED. REASON FOR EXPLANT IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 24639837 ↗InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED AT A NEW POCKET SITE.
Patient problems: Implant Pain
MAUDE report 24628004 ↗InjuryMar 6, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE THERAPIES WITH THE EXISTING SYSTEM. AS A RESULT, THE IPG WAS REMOVED AT AN UNKNOWN DATE TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24532110 ↗InjuryMar 2, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT¿S IPG AND LEAD WERE EXPLANTED. THE DATE OF EXPLANT AND REASON FOR EXPLANT ARE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 24484103 ↗InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE GENERATOR SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHERE IPG WAS REPLACED TO RESOLVE THE ISSUE.
Patient problems: Implant Pain
MAUDE report 24474819 ↗InjuryFeb 27, 2026Improper 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 EXTERNALS DEVICES. AS RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN AT AN UNKNOWN DATE WHEREIN THE DEVICE WAS REMOVED.
Patient problems: Inadequate Pain Relief
MAUDE report 24474736 ↗InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT GOT A POST-OPERATIVE INFECTION AND THE IPG WAS EXPLANTED TO ADDRESS THE ISSUE AT IN (B)(6) 2025. THE INFECTION PERSISTED AND AS SUCH, THE PATIENT RETURNED FOR SURGERY ON (B)(6) 2025 WHERE THE PRIOR IPG POCKET WAS WASHED OUT AND THE LEAD WAS EXPLANTED DUE TO BACK PAIN.
Patient problems: Unspecified Infection
MAUDE report 24472136 ↗InjuryFeb 10, 2026Improper or Incorrect Procedure or Method
IT WAS REPORTED THE PATIENT DID NOT RECHARGE THEIR IPG AS RECOMMENDED. AS SUCH, THE IPG BECAME INOPERABLE. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE.
Patient problems: Inadequate Pain Relief
MAUDE report 24310824 ↗InjuryFeb 5, 2026Improper 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 MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24275015 ↗InjuryFeb 2, 2026Wireless Communication Problem
IT WAS REPORTED THE PATIENT'S IPG WAS INOPERABLE. SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE IPG WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS CONFIRMED.
Patient problems: Inadequate Pain Relief
MAUDE report 24233074 ↗InjuryJan 29, 2026Wireless 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) 2026 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24216780 ↗InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT EXPERIENCED PAIN AT THE IPG SITE WITH THE 3788 EON MINI AND THE DEVICE WAS REPOSITIONED ON (B)(6) 2013 TO ADDRESS THE ISSUE. PATIENT¿S 3660 PROCLAIM SYSTEM WAS SHUTTING OFF UNINTENTIONALLY AND NOT PROVIDING EFFECTIVE STIMULATION. SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2023 WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT IS ASSOCIATED WITH THE ISSUE.
Patient problems: Implant Pain
MAUDE report 24215591 ↗
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, ClassifiedEterna SCS IPG (Implantable Pulse Generator), Model Number 32400
- Z-2507-2023 · Jul 18, 2023 · Open, ClassifiedProclaim 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-2510-2023 · Jul 18, 2023 · Open, ClassifiedInfinity 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, ClassifiedProclaim 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-2506-2023 · Jul 18, 2023 · Open, ClassifiedProclaim" 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-2511-2023 · Jul 18, 2023 · Open, ClassifiedInfinity 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, ClassifiedProclaim 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, ClassifiedProclaim 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-2692-2017 · Jun 2, 2017 · TerminatedProclaim 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 · TerminatedProclaim 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 · TerminatedEon 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 · TerminatedThe 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 · TerminatedEon - 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 · TerminatedSoftware 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
Other STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF devices
- Octrode™ 3186St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF30 deaths32,096 reports
- Intellis™ AdaptiveStim® 97715Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 deaths23,976 reports
- RestoreSensor™SureScan® 97714Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF6 deaths17,903 reports
- Proclaim™ 3660St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 recalls25 deaths13,336 reports
- Intellis™ AdaptiveStim® 97715Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF11,487 reports
- Precision Spectra ™ SC-1132Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF53 deaths11,269 reports
- Proclaim™ 5 EliteSt. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall10 deaths9,661 reports
- Proclaim™ 7 EliteSt. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall12 deaths7,299 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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