Eon CRecalls & reported problems across all models
St. Jude Medical, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 386
- Deaths reported
- 2
- Injuries reported
- 371
- Recalls
- 0
We found 3 models of Eon C by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 386 adverse event reports in the FDA's MAUDE database, received between May 31, 2018 and Jun 10, 2026 — classified as 2 deaths, 371 injuries, 13 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (85 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 C problems
Device problems
- Insufficient Device Problem Information85
- Adverse Event Without Identified Device or Use Problem68
- Wireless Communication Problem65
- No Device Output50
- Battery Problem49
- Therapeutic or Diagnostic Output Failure45
- Premature End-of-Life Indicator9
- Communication or Transmission Problem8
Patient problems
- Inadequate Pain Relief286
- No Consequences Or Impact To Patient40
- No Known Impact Or Consequence To Patient12
- Pain12
- Failure of Implant11
- Discomfort10
- No Clinical Signs, Symptoms or Conditions9
- Unspecified Infection7
Eon C models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Eon C™ 3688STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 deaths349 reports
- Eon C™ 3688STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF36 reports
- Eon C™ 3688STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 report
Recent Eon C adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJun 10, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENTS IPG WAS EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 25461931 ↗InjuryNov 20, 2025Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE PATIENT¿S IPG HAD REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON AN UNKNOWN DATE WHEREIN THE IPG WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 23612657 ↗InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG SITE FOLLOWING WEIGHT LOSS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE SYSTEM WAS EXPLANTED.
Patient problems: Implant Pain
MAUDE report 22311386 ↗InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AT THE IPG SITE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Implant Pain
MAUDE report 20186029 ↗InjuryAug 7, 2024Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT THE PATIENT'S IPG WAS DEPLETED AND WOULD NOT CHARGE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.
Patient problems: Inadequate Pain Relief
MAUDE report 19925488 ↗InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED AN INFECTION WAS PRESENT AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN IN 2013 WHEREIN THE SYSTEM WAS EXPLANTED, AND PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS TO ADDRESS THE ISSUE.
Patient problems: Unspecified Infection
MAUDE report 19461178 ↗InjuryMay 22, 2024Battery Problem; Wireless Communication Problem; Battery Problem; Wireless Communication Problem
IT WAS REPORTED THAT THE PATIENT'S RECHARGEABLE IPG WAS INOPERABLE. SURGICAL INTERVENTION MAY BE UNDERTAKEN AT A LATER DATE TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 19371767 ↗InjuryMar 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE IPG WAS EXPLANTED FOR AN UNKNOWN REASON. DATE OF EXPLANT IS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 18862333 ↗InjurySep 14, 2023Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT THE PATIENT'S 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 17752870 ↗InjuryAug 7, 2023Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT THE PATIENT'S IPG BECAME INOPERABLE. IT IS UNKNOWN IF THE DEVICE HAD PREMATURELY DEPLETED. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE IPG WAS EXPLANTED AND REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 17476781 ↗InjuryJun 20, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PATIENT'S IPG BECAME INOPERABLE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 IN WHICH THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 17162611 ↗InjuryJun 16, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PATIENT'S IPG WAS INOPERABLE DUE TO A DEAD BATTERY. SURGICAL INTERVENTION TOOK PLACE WHERE THE IPG WAS EXPLANTED AND REPLACED. THERAPY RESTORED POST PROCEDURE.
Patient problems: Inadequate Pain Relief
MAUDE report 17143666 ↗InjuryJun 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS EXPLANTED AT A UNKNOWN DATE FOR A UNKNOWN REASON. NO OTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 17075701 ↗InjuryMar 21, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PATIENT'S IPG WAS AT END OF LIFE. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE IPG WAS EXPLANTED AND REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 16583032 ↗InjuryFeb 16, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT PATIENTS IPG BECAME INOPERABLE. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 16386195 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page