Axium™ MN10350-90ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05415067025524), received between Jul 26, 2018 and Dec 25, 2019 — classified as 6 injuries.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 25, 2019Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER 1627487-2019-14235, 1627487-2019-14236, 1627487-2019-14238, 1627487-2019-14239. IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE STIMULATION. AS A RESULT, PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE LEADS AND IPG WERE EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9517744 ↗
• InjuryDec 25, 2019Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER 1627487-2019-14235, 1627487-2019-14237, 1627487-2019-14238, 1627487-2019-14239. IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE STIMULATION. AS A RESULT, PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE LEADS AND IPG WERE EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9517741 ↗
• InjuryJun 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REFERENCE MFR. REPORT#1627487-2019-05571, REFERENCE MFR. REPORT#1627487-2019-05572, REFERENCE MFR. REPORT#1627487-2019-06708. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2019 WHEREIN ALL 4 LEADS WERE EXPLANTED AND REPLACED THUS RESOLVING THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8682516 ↗
• InjurySep 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BEGAN TO VOMIT PRIOR TO ANY DEVICE BEING IMPLANTED, DURING HIS DRG TRIAL SURGERY. AS A RESULT, A DRG KIT WAS OPENED BUT WAS NOT USED, AND THE FACILITY DISPOSED IT; AND THE PHYSICIAN ABANDONED THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7862028 ↗
• InjuryJul 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 1 OF 2. REFERENCE MFR. REPORT# 1627487-2018-05933. IT WAS REPORTED DURING A PERMANENT PROCEDURE THE PHYSICIAN UNINTENTIONALLY IMPLANTED TWO TRIAL LEADS. HOWEVER, EFFECTIVE THERAPY WAS ESTABLISHED POST OPERATIVELY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7723589 ↗
• InjuryJul 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 2 OF 2, REFERENCE MFR. REPORT# 1627487-2018-05932. IT WAS REPORTED DURING A PERMANENT PROCEDURE THE PHYSICIAN UNINTENTIONALLY IMPLANTED TWO TRIAL LEADS. HOWEVER, EFFECTIVE THERAPY WAS ESTABLISHED POST OPERATIVELY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7723588 ↗