Axium™ MN10550-50Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 05415067025562), received between Jul 11, 2018 and Nov 6, 2022 — classified as 22 injuries.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryNov 6, 2022Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-06048. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE THERAPY. DIAGNOSTICS SHOWED NORMAL IMPEDANCE. SURGICAL INTERVENTION TOOK PLACE WHEREIN THE EXTENSION WAS EXPLANTED AND REPLACED WITH A NEW EXTENSION TO ADDRESS THE ISSUE. HOWEVER, NO THERAPY WAS ABLE TO BE ESTABLISHED DESPITE ADEQUATE LEAD POSITIONED. AS SUCH, ADDITIONAL SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15741279 ↗
• InjuryMar 14, 2022Low impedance; Low impedance

  ADDITIONAL INFORMATION REVEALED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION ON 30MAR2022 WHEREIN THE EXTENSION WAS CUT AND EXPLANTED AND A NEW LEAD WAS IMPLANTED. POSTOPERATIVELY, THE PATIENT HAS EFFECTIVE THERAPY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 13763152 ↗
• InjuryDec 13, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-18178, 1627487-2021-18180. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. IN TURN, THE IPG WAS EXPLANTED ON (B)(6) 2017. ADDITIONAL INFORMATION INDICATES ONE LEAD AND ONE EXTENSION WERE ALSO EXPLANTED ON (B)(6) 2021.

  Patient problems: Inadequate Pain Relief

  MAUDE report 12985118 ↗
• InjuryNov 16, 2020Disconnection; Disconnection

  RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2020-47753. 1627487-2020-47754. 1627487-2020-47755. IT WAS REPORTED THAT THE LEAD LOCATED AT T3 PULLED OUT. SURGERY MAY OCCUR TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH DEVICES ARE RELATED TO THE ISSUE, SO ALL SUSPECTED DEVICES ARE BEING REPORTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10841938 ↗
• InjuryNov 16, 2020Disconnection; Disconnection

  RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2020-47753; 1627487-2020-47754; 1627487-2020-47756. IT WAS REPORTED THAT THE LEAD LOCATED AT T3 PULLED OUT. SURGERY MAY OCCUR TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH DEVICES ARE RELATED TO THE ISSUE, SO ALL SUSPECTED DEVICES ARE BEING REPORTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10841937 ↗
• InjuryJun 1, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  DEVICE 5 OF 5: REFERENCE MFR. REPORT#: 1627487-2020-21222. REFERENCE MFR. REPORT#: 1627487-2020-21223. REFERENCE MFR. REPORT#: 1627487-2020-21224. REFERENCE MFR. REPORT#: 1627487-2020-21225. IT WAS REPORTED THE PATIENT HAD BEEN RECEIVING INEFFECTIVE THERAPY. IN TURN, THE PATIENT DECIDED TO HAVE THEIR DRG SYSTEM EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10105851 ↗
• InjuryJun 1, 2020Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  DEVICE 4 OF 5. REFERENCE MFR. REPORT#: 1627487-2020-21222. REFERENCE MFR. REPORT#: 1627487-2020-21223. REFERENCE MFR. REPORT#: 1627487-2020-21224. REFERENCE MFR. REPORT#: 1627487-2020-21226. IT WAS REPORTED THE PATIENT HAD BEEN RECEIVING INEFFECTIVE THERAPY. IN TURN, THE PATIENT DECIDED TO HAVE THEIR DRG SYSTEM EXPLANTED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 10105848 ↗
• InjuryMar 2, 2020Disconnection; High impedance; Disconnection; High impedance

  REGULATORY MANUFACTURER REPORT NUMBER: 1627487-2020-01791. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION DUE TO AN INABILITY TO INCREASE AMPLITUDE. IN TURN, A SYSTEM CHECK WAS PERFORMED THAT INDICATED THE L3 LEAD HAD HIGH IMPEDANCE ON ALL FOUR CONTACTS. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2020, WHEREIN IT WAS DISCOVERED THAT THE L3 LEAD WAS SLIGHTLY PULLED OUT OF THE EXTENSION HEADER. THE PHYSICIAN DECIDED TO DISCONNECT THE EXTENSION AND CUT IT TO REMOVE IT. REPORTEDLY, THE L3 LEAD WAS RETESTED AND ALL IMPEDANCE WERE WITHIN NORMAL RANGE. THERAPY WAS RESTORED POST OPERATIVELY.

  Patient problems: Inadequate Pain Relief

  MAUDE report 9776029 ↗
• InjuryFeb 21, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  MANUFACTURER REPORT NUMBER 1627487-2020-01899. IT WAS REPORTED THAT ONE OF THE PATIENT'S EXISTING LEAD EXTENSIONS WOULD NOT LOCK TO AN EXISTING DRG LEAD DURING A POCKET REVISION ON (B)(6) 2020 (REFERENCE REG REPORT: 1627487-2020-01555). IN TURN, THE EXISTING LEAD EXTENSION WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD EXTENSION IS RELATED TO THE ISSUE. THEREFORE, ALL THE SUSPECTED DEVICES ARE BEING REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9741040 ↗
• InjuryFeb 21, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  MANUFACTURER REPORT NUMBER 1627487-2020-01902. IT WAS REPORTED THAT ONE OF THE PATIENT'S EXISTING LEAD EXTENSIONS WOULD NOT LOCK TO AN EXISTING DRG LEAD DURING A POCKET REVISION ON (B)(6) 2020 (REFERENCE REG REPORT: 1627487-2020-01555). IN TURN, THE EXISTING LEAD EXTENSION WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. IT IS UNKNOWN WHICH LEAD EXTENSION IS RELATED TO THE ISSUE. THEREFORE, ALL THE SUSPECTED DEVICES ARE BEING REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9741036 ↗
• InjuryDec 4, 2019Therapeutic or Diagnostic Output Failure; Insufficient Device Problem Information; Wireless Communication Problem; Therapeutic or Diagnostic Output Failure; Insufficient Device Problem Information; Wireless Communication Problem

  RELATED MANUFACTURER REFERENCE# 1627487-2019-13513, 1627487-2019-13514, 1627487-2019-13516 & 1627487-2019-13515. IT WAS REPORTED THE PATIENT'S DRG SYSTEM WILL BE EXPLANTED. THE EXACT EXPLANT DATE AND REASON IS UNKNOWN.

  Patient problems: Inadequate Pain Relief; No Consequences Or Impact To Patient

  MAUDE report 9412220 ↗
• InjuryNov 7, 2019Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  REFERENCE MFR. REPORT#: 1627487-2019-12446, 1627487-2019-12449, 1627487-2019-12521, 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 9293739 ↗
• InjuryNov 7, 2019Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  REFERENCE MFR. REPORT#: 1627487-2019-12448; 1627487-2019-12449; 1627487-2019-12521; 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 9293733 ↗
• InjuryAug 22, 2019Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-09535. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-09537. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-09539. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-09542. IT WAS REPORTED THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION. REPROGRAMMING WAS PERFORMED; HOWEVER, IT WAS UNABLE TO PROVIDE EFFECTIVE THERAPY. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE DRG SYSTEM WAS EXPLANTED. THIS ADDRESSED THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8923120 ↗
• InjuryAug 22, 2019Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-09535. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-09537. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-09540. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-09542. IT WAS REPORTED THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION. REPROGRAMMING WAS PERFORMED; HOWEVER, IT WAS UNABLE TO PROVIDE EFFECTIVE THERAPY. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE DRG SYSTEM WAS EXPLANTED. THIS ADDRESSED THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8923113 ↗
• InjuryAug 22, 2019Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-09535. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-09539. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-09540. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-09542. IT WAS REPORTED THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION. REPROGRAMMING WAS PERFORMED; HOWEVER, IT WAS UNABLE TO PROVIDE EFFECTIVE THERAPY. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE DRG SYSTEM WAS EXPLANTED. THIS ADDRESSED THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8923108 ↗
• InjuryJun 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2019-06352. 1627487-2019-06353. 1627487-2019-06355. 1627487-2019-06356.

  Patient problems: Fever

  MAUDE report 8669201 ↗
• InjuryJun 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2019-06352, 1627487-2019-06354, 1627487-2019-06355, 1627487-2019-06356.

  Patient problems: Fever

  MAUDE report 8669200 ↗
• InjuryApr 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 3 OF 3. REFERENCE MFR. REPORT #: 1627487-2019-04871, REFERENCE MFR. REPORT #: 1627487-2019-05037. IT WAS REPORTED THE PATIENT DEVELOPED AN INFECTION (LOCATION UNKNOWN). AS SUCH, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE DRG SYSTEM WAS EXPLANTED (DATE UNKNOWN).

  Patient problems: Unspecified Infection

  MAUDE report 8558346 ↗
• InjuryAug 10, 2018Difficult to Remove; Difficult to Remove

  DEVICE 2 OF 2, REFERENCE MFR REPORT: 1627487-2018-07479. IT WAS REPORTED DURING THE PATIENT'S PERMANENT DRG SYSTEM IMPLANT PROCEDURE AFTER THE TRIAL, THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING ONE OF THE TRIAL EXTENSIONS. REPORTEDLY, THE PHYSICIAN HAD A DIFFICULT TIME BACKING OUT THE SET SCREW FOR ONE OF THE EXTENSIONS, THE SCREW WAS ABLE TO TORQUE DOWN, BUT NOT BACK OUT. THE PHYSICIAN USED A HEX WRENCH AND HE WAS ABLE TO UNLOCK THE EXTENSION, AND BOTH EXTENSIONS WERE REMOVED. THE PROCEDURE WAS COMPLETED AND NO FURTHER INTERVENTION WAS NECESSARY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7774287 ↗
• InjuryAug 10, 2018Difficult to Remove; Difficult to Remove

  DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2018-07480. IT WAS REPORTED DURING THE PATIENT'S PERMANENT DRG SYSTEM IMPLANT PROCEDURE AFTER THE TRIAL, THE PHYSICIAN EXPERIENCED DIFFICULTY REMOVING ONE OF THE TRIAL EXTENSIONS. REPORTEDLY, THE PHYSICIAN HAD A DIFFICULT TIME BACKING OUT THE SET SCREW FOR ONE OF THE EXTENSIONS, THE SCREW WAS ABLE TO TORQUE DOWN, BUT NOT BACK OUT. THE PHYSICIAN USED A HEX WRENCH AND HE WAS ABLE TO UNLOCK THE EXTENSION, AND BOTH EXTENSIONS WERE REMOVED. THE PROCEDURE WAS COMPLETED AND NO FURTHER INTERVENTION WAS NECESSARY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7774282 ↗
• InjuryJul 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE 3 OF 3: REFERENCE MFR. REPORT#1627487-2018-06385; REFERENCE MFR. REPORT#1627487-2018-06389. IT WAS REPORTED THE PATIENT EXPERIENCED INEFFECTIVE PAIN RELIEF DUE TO MIGRATION OF THEIR DRG LEAD. REPORTEDLY, X-RAYS CONFIRMED THE ISSUE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2018 WHEREIN 2 OF THE 3 ORIGINAL DRG LEADS WERE EXPLANTED AND REPLACED WITH NEW MODELS. POSTOPERATIVELY, STIMULATION WAS RESTORED AND THE ISSUE RESOLVED. NOTE: ALL DRG LEADS ARE BEING REPORTED AS IT'S UNKNOWN WHICH LEADS CONTRIBUTED TO THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 7677536 ↗