AxiumRecalls & reported problems across all models
St. Jude Medical, Inc. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 489
- Deaths reported
- 0
- Injuries reported
- 482
- Recalls
- 0
We found 2 models of Axium by St. Jude Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 489 adverse event reports in the FDA's MAUDE database, received between Jun 11, 2018 and Mar 30, 2026 — classified as 482 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Wireless Communication Problem” (72 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 Axium problems
Device problems
- Adverse Event Without Identified Device or Use Problem147
- Wireless Communication Problem72
- Battery Problem66
- Insufficient Device Problem Information65
- Therapeutic or Diagnostic Output Failure51
- No Device Output29
- Disconnection11
- High impedance11
Patient problems
- Inadequate Pain Relief338
- Pain40
- Discomfort29
- No Consequences Or Impact To Patient21
- No Clinical Signs, Symptoms or Conditions18
- Implant Pain13
- Insufficient Information12
- No Known Impact Or Consequence To Patient12
Axium models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Axium™ MN10200Dorsal root ganglion stimulator for pain relief484 reports
- Axium™ MN10600-02Dorsal root ganglion stimulator for pain relief5 reports
Recent Axium adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryMar 30, 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 24724059 ↗InjuryMar 5, 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 24520455 ↗InjuryOct 31, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT IS SCHEDULED FOR REPLACEMENT OF THEIR IPG. IT IS UNKNOWN WHY THE IPG IS PLANNED TO BE REPLACED. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23440988 ↗InjuryOct 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS EXPLANTED FOR AN UNKNOWN REASON. FURTHER INFORMATION IS UNAVAILABLE.
Patient problems: Insufficient Information
MAUDE report 23301034 ↗InjuryAug 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT PATIENTS SYSTEM WAS EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON. DURING THE EXPLANT PROCEDURE A PORTION OF THE PATIENTS LEAD BROKE OFF AN REMAINS IMPLANTED. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO REMOVE REMAINING PORTION OF LEAD. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT IS ASSOCIATED WITH THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 22800249 ↗InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE PATIENT EXPERIENCED PAIN AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. D10.
Patient problems: Implant Pain
MAUDE report 22298106 ↗InjuryAug 4, 2024Battery Problem; Wireless Communication Problem; Battery Problem; Wireless Communication Problem
ADDITIONAL INFORMATION RECEIVED INDICATED PATIENT UNDERWENT SURGICAL INTERVENTION WHERE THE IPG WAS REPLACED AND THERAPY RESTORED.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 19902977 ↗InjuryJun 16, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED PATIENT'S SYSTEM WAS EXPLANTED AT UNKNOWN DATE AND FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 19545027 ↗InjuryMay 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IPG AND LEADS WERE PROTRUDING FROM THE PATIENT'S BODY. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Implant Pain; Pocket Erosion
MAUDE report 19222391 ↗InjuryMar 19, 2024No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
ADDITIONAL INFORMATION INDICATES THAT THE DEVICE MEETS OR EXCEEDS 75% EXPECTED LONGEVITY. THERE IS NO ALLEGED STATED DEFICIENCY OR MALFUNCTION OF THE DEVICE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18932882 ↗InjurySep 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN AT THE IPG SITE DUE TO SIGNIFICANT WEIGHT LOSS. AS A RESULT, THE PATIENT MAY UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE.
Patient problems: Implant Pain
MAUDE report 17802373 ↗InjuryJun 29, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THE PATIENT UNDERWENT SURGICAL INTERVENTION IN (B)(6) 2023 WHEREIN THE SYSTEM WAS EXPLANTED. NO FURTHER INFORMATION IS KNOWN AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 17232736 ↗InjuryMar 13, 2023Battery Problem; Battery Problem
ADDITIONAL INFORMATION RECEIVED INDICATES THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 16532851 ↗InjuryFeb 16, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT A EXPLANT FOR A UNKNOWN REASON. NO OTHER INFORMATION IS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 16386380 ↗InjuryJan 4, 2023Battery Problem; Wireless Communication Problem; Battery Problem; Wireless Communication Problem
IT WAS REPORTED THAT PATIENT'S NON-RECHARGEABLE IPG HAD REACHED END OF LIFE (EOL). NO FURTHER INFORMATION WAS PROVIDED. SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THIS ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 16100182 ↗
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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