N/A 9733879 (UDI 00613994480613)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00613994480613), received between Mar 1, 2017 and Sep 13, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2024Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT TRACKING WAS UNSTABLE. A FRACTURE WAS SUSPECTED. THIS RESULTED IN A SURGICAL DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20211933 ↗
• MalfunctionOct 5, 2022Use of Device Problem; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE TIP OF A PROBE INSTRUMENT WAS CRACKED AND DEFORMED, THE LINEAR BLUNT PROBE HAD A CORD DISCONNECTION, THE ADAPTER WAS MISSING SCREW FASTENINGS AND THE MOUNT WAS MISSING A GASKET. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15546767 ↗
• MalfunctionApr 11, 2022Degraded; Device Sensing Problem; Material Integrity Problem; Degraded; Device Sensing Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING THE NAVIGATION SYSTEM. IT WAS REPORTED THAT OUTSIDE OF A PROCEDURE A DISCONNECTION IS SUSPECTED (IT WILL BECOME UNDETECTABLE IF IT IS MOVED). THERE WAS NO PATIENT PRESENT. IT WAS ALSO NOTED THAT THE DISCONNECTION CAUSED THE INSTRUMENT TO INTERMITTENTLY TRACK AND WAS SUSPECTED TO BE CAUSE BY A WORN WIRE IN THE CABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14074255 ↗
• MalfunctionNov 3, 2020Device Sensing Problem; Device Sensing Problem

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SUSPECTED CAUSE OF THE REPORTED ISSUE WAS THE PROBE WAS FRACTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10778135 ↗
• MalfunctionJan 15, 2020Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE DURING INSPECTION THE TIP OF THE BLUNT PROBE WAS BENT.

  Patient problems: No Patient Involvement

  MAUDE report 9591867 ↗
• MalfunctionFeb 20, 2019Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THERE WAS DEFORMATION OF TIP OF THE LINEAR BLUNT PROBE. A PASSIVE PROBE WAS USED INSTEAD. THIS ISSUE WAS NOTED PREOPERATIVELY AND DID NOT CAUSE ANY SURGICAL DELAY. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8353989 ↗
• MalfunctionNov 13, 2018Display or Visual Feedback Problem; Electrical /Electronic Property Problem; Display or Visual Feedback Problem; Electrical /Electronic Property Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE SITE HAD A DAMAGED ACTIVE BLUNT PROBE. ONE LED LIGHT OF THE PROBE'S LONG CABLE WENT OUT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS OBSERVED. IT COULD NOT BE DETERMINED IF THE INSTRUMENT PASSED VERIFICATION.

  Patient problems: No Patient Involvement

  MAUDE report 8067493 ↗
• MalfunctionOct 23, 2018Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE CABLE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER CABLE. THERE WAS NO REPORTED IMPACT ON THE PATIENT¿S OUTCOME. THERE WAS ALSO NO REPORTED DELAY TO THE PROCEDURE DUE TO HIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7996752 ↗
• MalfunctionSep 28, 2017Communication or Transmission Problem; Communication or Transmission Problem

  A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A PROCEDURE ONE LED ON THE ACTIVE PROBE LONG CABLE WAS NOT COMMUNICATING WITH NAVIGATION SYSTEM. THE PROCEDURE WAS COMPLETED WITH THE USE OF NAVIGATION. THERE WAS NO DELAY TO PROCEDURE. NO IMPACT ON PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6901384 ↗
• MalfunctionMar 23, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A PROCEDURE, THE CABLE FOR A PROBE WAS REPORTED TO HAVE BEEN DAMAGED. THE REPORTED ISSUE OCCURRED FOLLOWING AN INCISION. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6429862 ↗
• MalfunctionMar 1, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  (B)(6) SUBMITTED MATTERS TO REPORT A LED FAILURE OF ACTIVE PLANAR PROBE. SURGERY COMPLETED WITHOUT NAVIGATION. SURGEON: DR. (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6368470 ↗