Axium™ MN10200Recalls & reported problems
St. Jude Medical, Inc. · Implantable Neurostimulator Kit · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This St. Jude Medical Axium stimulator sends electrical pulses to nerves near the spine to ease pain. Most of its 485 reports describe inadequate pain relief, and some describe wireless, battery or output problems. Recent reports describe systems removed for unknown reasons, and one describes a lead that broke off during removal and stayed in place. The reports include 478 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 484
- Deaths reported
- 0
- Injuries reported
- 477
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 484 adverse event reports that list this exact device (DI 05415067025500), received between Jun 11, 2018 and Mar 30, 2026 — classified as 477 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported 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 impedance10
Patient problems
- Inadequate Pain Relief333
- 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
Recent adverse event reports
The 25 most recent of 484 reports, 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 ↗InjuryDec 15, 2022Battery Problem; Battery Problem
IT WAS REPORTED THE PATIENT HAD THEIR DRG IPG REPLACED BECAUSE THE IPG WAS INOPERABLE. STIMULATION THERAPY WAS REPORTEDLY RESTORED POSTOPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15992705 ↗InjuryDec 7, 2022Battery Problem; Battery Problem
IT WAS REPORTED THE PATIENT HAD THEIR DRG IPG REPLACED BECAUSE THE IPG WAS INOPERABLE. STIMULATION THERAPY WAS REPORTEDLY RESTORED POSTOPERATIVELY. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-06677.
Patient problems: Inadequate Pain Relief
MAUDE report 15933763 ↗InjuryNov 15, 2022Battery Problem; Battery Problem
IT WAS REPORTED THE PATIENT¿S IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. A MANUFACTURER REPRESENTATIVE CONFIRMED THE ISSUE AND THE IPG DEEMED INOPERABLE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 15797375 ↗InjuryNov 10, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S DRG SYSTEM WAS EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 15777159 ↗InjuryNov 8, 2022Battery Problem; Battery Problem
IT WAS REPORTED THE PATIENT¿S IPG LOST COMMUNICATION WITH EXTERNAL DEVICES. IN TURN, THE IPG DEEMED INOPERABLE. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 15755660 ↗InjuryNov 7, 2022Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PATIENT'S IPG HAS REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION TOOK PLACE AND ADDRESSED THE ISSUE.
Patient problems: Failure of Implant; Inadequate Pain Relief
MAUDE report 15745225 ↗InjuryOct 24, 2022Battery Problem; Battery 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.
Patient problems: Inadequate Pain Relief
MAUDE report 15656819 ↗InjuryOct 7, 2022Battery Problem; Battery Problem
IT WAS REPORTED THE PATIENT¿S IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. A MANUFACTURER REPRESENTATIVE CONFIRMED THE ISSUE AND THE IPG WAS DEEMED INOPERABLE. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 15567065 ↗InjurySep 16, 2022Wireless Communication Problem; Wireless Communication Problem
IT WAS REPORTED THAT THE PATIENT'S IPG WAS NO LONGER OPERABLE. AS SUCH SURGICAL INTERVENTION TOOK PLACE WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 15441499 ↗InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT IS LEAN WHICH IS CAUSED THE IPG TO PROTRUDE RESULTING IN PAIN AT THE IPG SITE. AS SUCH SURGICAL INTERVENTION TOOK PLACE WHEREIN THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Implant Pain
MAUDE report 15441469 ↗
Other Dorsal root ganglion stimulator for pain relief devices
- SlimTip™ MN10450-50AAdvanced Neuromodulation Systems, Inc. · Dorsal root ganglion stimulator for pain relief7 deaths8,308 reports
- Proclaim™ DRGSt. Jude Medical, Inc. · Dorsal root ganglion stimulator for pain relief2 recalls8 deaths2,177 reports
- Axium™ MN10450-50ASpinal Modulation, Inc. · Dorsal root ganglion stimulator for pain relief1,836 reports
- SlimTip™ MN10450-90AAdvanced Neuromodulation Systems, Inc. · Dorsal root ganglion stimulator for pain relief8 deaths1,187 reports
- Axium™ MN10450-90ASpinal Modulation, Inc. · Dorsal root ganglion stimulator for pain relief443 reports
- SlimTip™ MN10350-50AAdvanced Neuromodulation Systems, Inc. · Dorsal root ganglion stimulator for pain relief3 deaths373 reports
- Axium™ MN10450-50ASpinal Modulation, Inc. · Dorsal root ganglion stimulator for pain relief81 reports
- Axium™ MN10350-50ASpinal Modulation, Inc. · Dorsal root ganglion stimulator for pain relief39 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 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