Eon MiniRecalls & reported problems across all models
St. Jude Medical, Inc. · 3 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4,873
- Deaths reported
- 1
- Injuries reported
- 4,845
- Recalls
- 0
We found 3 models of Eon Mini by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 4,873 adverse event reports in the FDA's MAUDE database, received between Apr 22, 2015 and Sep 28, 2026 — classified as 1 death, 4,845 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1,362 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Eon Mini problems
Device problems
- Improper or Incorrect Procedure or Method1,362
- Wireless Communication Problem1,282
- Adverse Event Without Identified Device or Use Problem568
- Therapeutic or Diagnostic Output Failure462
- Insufficient Device Problem Information441
- Use of Device Problem399
- No Device Output210
- Premature Discharge of Battery165
Patient problems
- Inadequate Pain Relief3,812
- No Consequences Or Impact To Patient301
- Insufficient Information155
- No Known Impact Or Consequence To Patient153
- No Clinical Signs, Symptoms or Conditions130
- Pain112
- Failure of Implant103
- Implant Pain77
Eon Mini models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Eon Mini™ 3788STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 death4,666 reports
- Eon Mini™ 3788STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF191 reports
- Eon Mini™ 3788STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF16 reports
Recent Eon Mini adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryApr 20, 2026Wireless Communication Problem
IT WAS REPORTED THE PATIENT¿S IPG HAD AN INCREASED RECHARGE BURDEN. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 24932084 ↗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 ↗
Other St. Jude Medical, Inc. products
- Tendril15 models · 49,498 reports
- Octrode10 models · 36,740 reports
- Proclaim12 models · 35,038 reports · 17 recalls
- Durata28 models · 19,805 reports
- Assurity MRI2 models · 17,838 reports · 1 recall
- Gallant8 models · 12,885 reports · 5 recalls
- Quartet10 models · 11,001 reports
- MitraClip19 models · 9,056 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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