EonRecalls & reported problems across all models
Advanced Neuromodulation Systems, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 770
- Deaths reported
- 0
- Injuries reported
- 763
- Recalls
- 0
We found 2 models of Eon by Advanced Neuromodulation Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 770 adverse event reports in the FDA's MAUDE database, received between Jun 26, 2018 and Apr 22, 2026 — classified as 763 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Wireless Communication Problem” (209 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 problems
Device problems
- Wireless Communication Problem209
- Improper or Incorrect Procedure or Method200
- Adverse Event Without Identified Device or Use Problem104
- Insufficient Device Problem Information72
- Therapeutic or Diagnostic Output Failure68
- Use of Device Problem51
- No Device Output35
- Premature Discharge of Battery29
Patient problems
- Inadequate Pain Relief575
- No Consequences Or Impact To Patient47
- Discomfort25
- Insufficient Information24
- No Known Impact Or Consequence To Patient22
- Pain21
- Failure of Implant18
- No Clinical Signs, Symptoms or Conditions18
Eon models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
Recent Eon adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 22, 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 24957442 ↗InjuryMar 16, 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 24604512 ↗InjuryFeb 10, 2026Wireless Communication Problem
IT WAS REPORTED THAT THE PATIENT'S IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. TROUBLESHOOTING HAS BEEN UNABLE TO RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN IN THE FUTURE.
Patient problems: Inadequate Pain Relief
MAUDE report 24310473 ↗InjuryDec 9, 2025Insufficient Device Problem Information; Insufficient 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 23760530 ↗InjurySep 11, 2025Improper or Incorrect Procedure or Method; Improper 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 23023198 ↗InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AT THE EXTENSION SITES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Implant Pain
MAUDE report 23023092 ↗InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED PAIN AT THE EXTENSION SITES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Implant Pain
MAUDE report 23023091 ↗InjurySep 2, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
IT WAS REPORTED PATIENT'S IPGS BECAME INOPERABLE DUE TO PATIENT STOPPED CHARGING. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THE ISSUES.
Patient problems: Inadequate Pain Relief
MAUDE report 22935501 ↗InjuryAug 25, 2025No Apparent Adverse Event; Wireless Communication Problem; No Apparent Adverse Event; Wireless Communication Problem
IT WAS REPORTED THAT THE PATIENT¿S ENTIRE SYSTEM WAS EXPLANTED ON AN (B)(6) 2025 FOR AN UNKNOWN REASON.
Patient problems: Failure of Implant; Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions
MAUDE report 22891468 ↗InjuryAug 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT¿S ENTIRE SYSTEM WAS EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 22879458 ↗InjuryAug 20, 2025Battery Problem; No Apparent Adverse Event; Battery Problem; No Apparent Adverse Event
ADDITIONAL INFORMATION INDICATED THE IPGS MET OR EXCEEDED 75% EXPECTED LONGEVITY. THERE IS NO DEVICE MALFUNCTION.
Patient problems: Failure of Implant; Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions
MAUDE report 22851349 ↗InjuryAug 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED PATIENT'S IPG WAS EXPLANTED AT AN UNKNOWN TIME DUE TO AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 22820321 ↗InjuryAug 15, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
IT WAS REPORTED THAT SURGICAL INTERVENTION TO EXPLANT THE SYSTEM MAY BE UNDERTAKEN FOR AN UNKNOWN REASON. ADDITIONAL INFORMATION IS NOT AVAILABLE AT THIS TIME.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22819260 ↗InjuryJul 28, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
ADDITIONAL INFORMATION RECEIVED INDICATES SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE SYSTEM WAS EXPLANTED.
Patient problems: Inadequate Pain Relief
MAUDE report 22639628 ↗InjuryJul 18, 2025Improper or Incorrect Procedure or Method; Improper 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 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 22544218 ↗
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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