Axium™ MN10350-50ARecalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 05415067025517), received between Jun 12, 2018 and May 27, 2026 — classified as 39 injuries.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Migration

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. X-RAY IMAGING REVEALED MIGRATION OF BOTH L5 AND S1 LEADS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2026 WHEREIN BOTH LEADS WERE EXPLANTED AND THE S1 LEAD WAS REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25310619 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE PATIENT WAS IMPLANTED WITH THEIR TRIAL LEAD THEY STARTED EXPERIENCING SEVERE PAIN IN THEIR C8 LEAD. SURGICAL INTERVENTION WAS UNDERTAKEN AND THEIR LEAD WAS EXPLANTED.

  Patient problems: Implant Pain

  MAUDE report 16099527 ↗
• InjuryJul 28, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER 1627487-2021-15944, 1627487-2021-15943. IT WAS REPORTED THE PATIENT STOPPED USING THEIR SCS SYSTEM DUE TO INADEQUATE STIMULATION. REPROGRAMMING DID NOT RESOLVE THE ISSUE. AS A RESULT, SURGICAL INTERVENTION TOOK PLACE WHERE THE ENTIRE SYSTEM WAS EXPLANTED.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 12235889 ↗
• InjuryNov 7, 2019Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  REFERENCE MFR. REPORT#: 1627487-2019-12446; 1627487-2019-12448; 1627487-2019-12449; 1627487-2019-12522. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION. AS A RESULT, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE PATIENT HAD THEIR ENTIRE SYSTEM EXPLANTED. THE EXACT DATE OF EXPLANT IS UNKNOWN.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9293765 ↗
• InjuryNov 7, 2019Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  REFERENCE MFR. REPORT#: 1627487-2019-12446; 1627487-2019-12448; 1627487-2019-12449; 1627487-2019-12521. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION. AS A RESULT, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE PATIENT HAD THEIR ENTIRE SYSTEM EXPLANTED. THE EXACT DATE OF EXPLANT IS UNKNOWN.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9293764 ↗
• InjuryMay 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT WAS UNDERGOING A DRG TRIAL WHEN THE PATIENT EXPERIENCED PAIN ALONG THE L3 DERMATOME TRACK THE DAY FOLLOWING IMPLANT. MAPPING REVEALED MOTOR STIMULATION, SO THE PHYSICIAN OPTED TO EXPLANT THE L3 LEAD ON (B)(6) 2019 WHILE LEAVING THE L4 TRIAL LEAD IMPLANTED. THE PATIENT¿S PAIN ASSOCIATED WITH THE L3 LEAD HAS SINCE RESOLVED.

  Patient problems: Pain; Therapeutic Effects, Unexpected

  MAUDE report 8624381 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REFERENCE MFR REPORT: 1627487-2019-05550. REFERENCE MFR REPORT: 1627487-2019-05551. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN IN THEIR LEFT SIDE (GROIN, HIP,AND BACK) AFTER THE BEGINNING OF THE DRG SYSTEM TRIAL. THE PAIN DID NOT RESOLVE ON ITS OWN AND THE TRAIL WAS ENDED PREMATURELY AS A RESULT. PATIENT ALSO HAD A SEIZURE IN POST-OP RECOVERY FOLLOWING THE TRIAL'S END. THE ISSUE HAS SINCE BEEN RESOLVED.

  Patient problems: Pain; Seizures

  MAUDE report 8600071 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REFERENCE MFR REPORT: 1627487-2019-05550. REFERENCE MFR REPORT: 1627487-2019-05552. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN IN THEIR LEFT SIDE (GROIN, HIP,AND BACK) AFTER THE TRIAL PROCEDURE. THE PAIN DID NOT RESOLVE ON ITS OWN AND THE TRAIL WAS ENDED PREMATURELY. PATIENT ALSO HAD A SEIZURE IN POST-OP RECOVERY FOLLOWING THE TRIAL'S END. THE ISSUE HAS SINCE BEEN RESOLVED.

  Patient problems: Pain; Seizures

  MAUDE report 8600070 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REFERENCE MFR REPORT: 1627487-2019-05551, REFERENCE MFR REPORT: 1627487-2019-05552. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN IN THEIR LEFT SIDE (GROIN, HIP, AND BACK) AFTER THE BEGINNING OF THE DRG SYSTEM TRIAL. THE PAIN DID NOT RESOLVE ON ITS OWN AND THE TRAIL WAS ENDED PREMATURELY AS A RESULT. PATIENT ALSO HAD A SEIZURE IN POST-OP RECOVERY FOLLOWING THE TRIAL'S END. THE ISSUE HAS SINCE BEEN RESOLVED.

  Patient problems: Pain; Seizures

  MAUDE report 8600067 ↗
• InjuryApr 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 1 OF 2, MFG REPORT REFERENCE: 1627487-2019-04213. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ABANDONED PROCEDURE. THE PHYSICIAN ATTEMPTED TO IMPLANTED TWO LEADS BUT WAS UNABLE TO DUE TO PATIENT ANATOMY. THE PROCEDURE WAS ABANDONED WITH NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8486785 ↗
• InjuryApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 1 OF 2, MFG REPORT REFERENCE: 1627487-2019-04174. IT WAS REPORTED THAT THE PATIENT WAS HAVING SYMPTOMS OF AN INFECTION DURING A TRIAL. THE PATIENT REPORTED FEVER, CHILLS AND PAIN AT THE PROCEDURE SITE. THE PATIENT WAS HOSPITALIZED AND RECEIVED A PIC LINE TO TREAT THE INFECTION. THE TRIAL WAS ENDED EARLY AND THE LEADS WERE REMOVED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 8482920 ↗
• InjuryApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 2 OF 2, MFG REPORT REFERENCE: 1627487-2019-04173. IT WAS REPORTED THAT THE PATIENT WAS HAVING SYMPTOMS OF AN INFECTION DURING A TRIAL. THE PATIENT REPORTED FEVER, CHILLS AND PAIN AT THE PROCEDURE SITE. THE PATIENT WAS HOSPITALIZED AND RECEIVED A PIC LINE TO TREAT THE INFECTION. THE TRIAL WAS ENDED EARLY AND THE LEADS WERE REMOVED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 8482916 ↗
• InjuryMar 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A TRIAL IMPLANT PROCEDURE, LEAD WAS ATTEMPTED TO BE IMPLANTED HOWEVER THE PROCEDURE WAS ABANDONED DUE TO THE PATIENT FEELING DISCOMFORT. NO ADVERSE EVENTS WERE REPORTED. PATIENT WAS STABLE OTHERWISE.

  Patient problems: Discomfort

  MAUDE report 8453719 ↗
• InjuryMar 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CEREBROSPINAL FLUID (CSF) LEAK. DURING A PROCEDURE FOR A DRG TRIAL LEAD IMPLANT, A CEREBROSPINAL FLUID LEAK OCCURRED. THE PROCEDURE WAS ABANDONED. THE ISSUE HAS BEEN RESOLVED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 8436260 ↗
• InjuryFeb 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 2 OF 2. REFERENCE MFR. REPORT: 1627487-2019-02729. FOLLOW UP INFORMATION IDENTIFIED THE PATIENT HAD A FAILED TRIAL, AND THE LEADS WERE EXPLANTED, AS PREVIOUSLY REPORTED. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: Pain

  MAUDE report 8379506 ↗
• InjuryFeb 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 1 OF 2. REFERENCE MFR. REPORT: 1627487-2019-02730. FOLLOW UP INFORMATION IDENTIFIED THE PATIENT HAD A FAILED TRIAL, AND THE LEADS WERE EXPLANTED, AS PREVIOUSLY REPORTED. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: Pain

  MAUDE report 8379505 ↗
• InjuryJan 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A PERMANENT IMPLANT PROCEDURE THE PHYSICIAN CUT A PORTION OF THE STYLET AND LEFT IT IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION IS PENDING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8294820 ↗
• InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT'S L4 DRG LEAD HAD MIGRATED. THE PATIENT UNDERWENT SURGICAL INTERVENTION WHERE THE LEAD WAS REPLACED WITH A NEW ONE. STIMULATION WAS REPORTEDLY RESTORED POSTOPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8237788 ↗
• InjuryJan 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ABANDONED PROCEDURE OCCURRED ON (B)(6) 2018 DUE TO SEDATION ISSUES. THE PATIENT WAS RESCHEDULED FOR SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8212724 ↗
• InjuryNov 5, 2018Fracture; Fracture

  DEVICE 1 OF 2 REFERENCE MFR. REPORT#: 1627487-2018-11265. IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING ADEQUATE THERAPY, DUE TO LEAD MIGRATION AND FRACTURE CONFIRMED VIA X-RAYS. AS RESULT, THE PATIENT'S LEADS WERE EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST-OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8040226 ↗
• InjuryOct 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 1 OF 2. REFERENCE MFR. REPORT: 1627487-2018-09968. IT WAS REPORTED THE TRIAL PATIENT WAS RUSHED TO EMERGENCY ROOM DUE TO INFLAMMATION. AS A RESULT, THE PATIENT WAS TREATED WITH STEROIDS. THE INFLAMMATION HAS BEEN RESOLVED.

  Patient problems: Inflammation

  MAUDE report 7962637 ↗
• InjuryOct 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 2 OF 2. REFERENCE MFR. REPORT: 1627487-2018-09967. IT WAS REPORTED THE TRIAL PATIENT WAS RUSHED TO EMERGENCY ROOM DUE TO INFLAMMATION. AS A RESULT, THE PATIENT WAS TREATED WITH STEROIDS. THE INFLAMMATION HAS BEEN RESOLVED.

  Patient problems: Inflammation

  MAUDE report 7962636 ↗
• InjuryAug 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL, CAUSING HIS LEAD TO MIGRATE OUT OF PLACE. AS A RESULT, THE PATIENT'S L5 DRG LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: Fall

  MAUDE report 7813865 ↗
• InjuryAug 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 2 OF 2: REFERENCE MFR. REPORT: 1627487-2018-07719. IT WAS REPORTED THE PATIENT UNDERWENT A DRG TRIAL PROCEDURE ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT REPORTED BACK PAIN, SWEATING, POSSIBLE FEVER AND FELT SICK AND BEDRIDDEN. AS SUCH, THE TRIAL ENDED DUE TO PATIENT SYMPTOMS AND THE LEADS WERE REMOVED. THE SYMPTOMS HAVE RESOLVED SINCE LEAD REMOVAL.

  Patient problems: Fever; Pain; Sweating

  MAUDE report 7811189 ↗
• InjuryAug 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 1 OF 2 REFERENCE MFR. REPORT: 1627487-2018-07911. IT WAS REPORTED THE PATIENT UNDERWENT A DRG TRIAL PROCEDURE ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT REPORTED BACK PAIN, SWEATING, POSSIBLE FEVER AND FELT SICK AND BEDRIDDEN. AS SUCH, THE TRIAL ENDED DUE TO PATIENT SYMPTOMS AND THE LEADS WERE REMOVED. THE SYMPTOMS HAVE RESOLVED SINCE LEAD REMOVAL.

  Patient problems: Fever; Pain; Sweating

  MAUDE report 7811175 ↗