AxiEM 9733367Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994333780), received between Oct 31, 2018 and Oct 31, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2018Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THE TRACER PROBE STOPPED TRACKING INTRAOPERATIVELY. THE TRACER PROBE WAS REPORTEDLY DAMAGED. THE SITE HAD SUCCESSFULLY REGISTERED THE PATIENT, THEN BEGAN MOVING THE PATIENT¿S HEAD TO BEGIN SURGERY. THE MEDTRONIC REPRESENTATIVE (REP) ON SITE NOTICED MOVEMENT IN THE PATIENT REFERENCE FRAME WHILE THE SITE WAS MOVING THE PATIENT¿S HEAD. THE REP HAD THE SITE CHECK ACCURACY, AND THEY WERE NO LONGER ACCURATE. THE SITE SWITCHED PATIENT TRACKERS AND BEGAN DOING ANOTHER REGISTRATION. WHILE REGISTERING THE SECOND TIME, THE TRACER PROBE WAS NOT TRACKING. THE PORT ON THE AXIEM BOX WAS GREEN; THE REP MOVED THE EMITTER AND COULD NOT GET THE PROBE TO TRACK. THE TRACER PROBE WAS REPLACED, AND THE NEW PROBE SUCCESSFULLY TRACKED. THE SITE WAS ABLE TO REGISTER AND CONTINUE THE CASE. THERE WAS A SURGICAL DELAY OF LESS THAN 1 HOUR DUE TO THIS ISSUE, AND THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8026583 ↗