Eon MiniRecalls & reported problems across all models
Advanced Neuromodulation Systems, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls
- 0
We found 3 models of Eon Mini by Advanced Neuromodulation Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Jun 26, 2018 and Jun 2, 2025 — classified as 33 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Temperature Problem” (10 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
- Temperature Problem10
- Wireless Communication Problem8
- Improper or Incorrect Procedure or Method5
- High impedance4
- Adverse Event Without Identified Device or Use Problem3
- Premature Discharge of Battery2
- Therapeutic or Diagnostic Output Failure2
- Charging Problem1
Patient problems
- Inadequate Pain Relief20
- Burning Sensation8
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient3
- Death1
- Discomfort1
- Failure of Implant1
- Pain1
Eon Mini models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Eon Mini™ 3721STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF16 reports
- Eon Mini™ 3722STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF12 reports
- Eon Mini™ 3720STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF9 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.
InjuryJun 2, 2025High impedance; High impedance
IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE THERAPY DUE TO HIGH IMPEDANCES ON L1 AND L4-L5 LEADS. AS A RESULT, SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22128083 ↗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 ↗InjuryOct 12, 2022Temperature Problem; Temperature Problem
RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-05637. IT WAS REPORTED THE PATIENT EXPERIENCED POCKET HEATING WHILE RECHARGING THEREFORE HAS STOPPED CHARGING. AS A RESULT, A NEW CHARGER MAY BE GIVEN TO THE PATIENT TO ADDRESS THE ISSUE. ON 08/01/2012 ST. JUDE MEDICAL, NEUROMODULATION DIVISION, SENT FIELD ACTION LETTERS TO PATIENTS RELATED TO HEATING WHILE CHARGING AND RAISED AWARENESS OF THIS ISSUE TO PATIENTS. AN INCREASE IN PRIOR NON-REPORTED HEATING WHILE CHARGING EVENTS AND OTHER NON-REPORTED EVENTS WAS EXPECTED.
Patient problems: Burning Sensation
MAUDE report 15592206 ↗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 ↗InjuryMay 3, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED THE PATIENT LOST THERAPY DUE TO NOT CHARGING THE IPG. THE ISSUE WAS RESOLVED THROUGH AN IPG REPLACEMENT. EFFECTIVE THERAPY RESTORED POST-OP.
Patient problems: Inadequate Pain Relief
MAUDE report 14266101 ↗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 ↗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 ↗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 12, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
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 IN WHICH THE IPG WAS EXPLANTED AND REPLACED, WHICH RESOLVED THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 12148457 ↗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 ↗
Other Advanced Neuromodulation Systems, Inc. products
All Advanced Neuromodulation Systems, Inc. devices →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.
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