N/A 9732585Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00613994110831), received between Feb 7, 2017 and Apr 9, 2019 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2019Imprecision; Human-Device Interface Problem; Imprecision; Human-Device Interface Problem

  ON 2019-2-05, (B)(4) (HCP REP FOR): MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL BIOPSY. IT WAS REPORTED THAT THE SITE USED THE MR TO PLAN AND PERFORM NAVIGATION. DURING THE PROCEDURE THERE WERE NO SIGNS OF INACCURACY. THE SITE TOOK A POST-OP CT SCAN AND NOTICED THEY HAD UNSUCCESSFULLY PERFORMED THE SURGERY, AND BIOPSIED HEALTHY TISSUE. THE SITE MERGED THE CT WITH THE MR AND IT SHOWED A 5MM DEVIATION FROM TARGET PLANNED. THERE WAS NO REPORTED DELAY TO PROCEDURE. THE SITE HAD TO SCHEDULE ANOTHER SURGERY AND WAS PERFORMED WITHOUT MEDTRONIC NAVIGATION. IT WAS NOTED THAT THE LIKELY CAUSE OF THE EVENT WAS A DISTORTED MR SCAN.

  Patient problems: No Known Impact Or Consequence To Patient; Tissue Damage

  MAUDE report 8495062 ↗
• MalfunctionMar 25, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE AXIEM BOX WAS BROKEN, DID NOT WORK PROPERLY, AND WAS SLOWING DOWN THE COMPUTER. IT WAS ALSO NOTED THAT THE FIELD GENERATOR DID NOT EMIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8449367 ↗
• MalfunctionMar 25, 2019Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THE HOSPITAL SENT THE CAMERA IN A DISASSEMBLED STATE, WHICH IS HOW IT WAS RECEIVED FOR ANALYSIS.

  Patient problems: No Patient Involvement

  MAUDE report 8449227 ↗
• InjuryMar 4, 2019Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL BIOPSY PROCEDURE. IT WAS REPORTED THAT DURING BIOPSY PROCEDURE THE SITE USED MAGNETIC RESONANCE IMAGING (MR) TO PLAN AND PERFORM NAVIGATION. A POST-OP COMPUTED TOMOGRAPHY (CT) WAS MERGED WITH THE MR AND SHOWED A 5MM DEVIATION FROM THE PLANNED TARGET. THERE WAS NO PATIENT IMPACT REPORTED AND NO DELAY TO SURGERY.

  Patient problems: Tissue Damage

  MAUDE report 8387768 ↗
• MalfunctionDec 5, 2018Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS A MALFUNCTION WITH THE NAVIGATION CAMERA. THE MALFUNCTION WAS DESCRIBED AS "FIELD OF VIEW CORRUPTED GOT SMALLER.¿ THE PROBLEM WAS THAT IN ORDER FOR THE CAMERA TO ¿¿SEE¿¿ THE TOOLS, IT NEEDED TO BE PLACED VERY CLOSE TO THE TOOLS. THE CAMERA HAD TO BE PLACED LESS THAN 50 CM FROM THE PROBE OR THE FRAME. ONE WOULD NOT HAVE BEEN ABLE TO PERFORM A NAVIGATION CASE WITH THIS ISSUE. IT WAS NOTED THAT THE CAMERA WAS UNUSABLE. THERE WAS NO PATIENT PRESENT AS THIS ISSUE OCCURRED IN A DEMO SETUP OF THE SYSTEM.

  Patient problems: No Patient Involvement

  MAUDE report 8136143 ↗
• MalfunctionSep 20, 2018Device Fell; Device Fell

  IT WAS REPORTED THAT THERE WAS DAMAGE TO THE MONITOR. AS THE REPRESENTATIVE WAS PULLING THE UNIT AWAY, THE MONITOR CAME OFF THE HINGE AND FELL ON THE TABLE, WHICH DAMAGED IT.

  Patient problems: No Patient Involvement

  MAUDE report 7894515 ↗
• MalfunctionJun 8, 2017Imprecision; Imprecision

  A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL RESECTION, AN IMPRECISION OCCURRED DURING THE PROCEDURE. IT WAS REPORTED THAT THE SURGEON PLACED THE REFERENCE FRAME 180 DEGREES OPPOSITE THE DIRECTION IT WAS ATTACHED FOR REGISTRATION. THE SURGEON UNSUCCESSFULLY ATTEMPTED TO PLACE A CATHETER INTO THE VENTRICLE. ONCE THE ORIENTATION OF THE FRAME WAS RESOLVED, THE SURGEON SUCCESSFULLY PLACED THE CATHETER WITH NAVIGATION. TOWARDS THE END OF THE PROCEDURE, THE SURGEON WAS UNABLE TO USE NAVIGATION AS THE BRAIN HAD SWELLED TOO MUCH AND WOULD HAVE BEEN INACCURATE. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6622946 ↗
• MalfunctionFeb 10, 2017No Display/Image; Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem

  A MEDTRONIC REPRESENTATIVE REPORTED A NAVIGATION SYSTEM CAMERA THAT WAS NOT SHOWING STATUS, POWER OR ANY TYPE OF COMMUNICATION. THE CAMERA WAS NOT RESPONDING TO THE NAVIGATION SYSTEM PROPERLY. NO FURTHER DETAILS REGARDING THE BEHAVIOR, OR SPECIFICALLY WHEN IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6324444 ↗
• MalfunctionFeb 10, 2017No Display/Image; Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem

  A MEDTRONIC REPRESENTATIVE REPORTED A NAVIGATION SYSTEM CAMERA THAT WAS NOT SHOWING STATUS, POWER OR ANY TYPE OF COMMUNICATION. THE CAMERA WAS NOT RESPONDING TO THE NAVIGATION SYSTEM PROPERLY. NO FURTHER DETAILS REGARDING THE BEHAVIOR, OR SPECIFICALLY WHEN IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 6324352 ↗
• MalfunctionFeb 7, 2017No Display/Image; Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem

  A MEDTRONIC REPRESENTATIVE REPORTED A NAVIGATION SYSTEM CAMERA THAT WAS NOT SHOWING STATUS, POWER OR ANY TYPE OF COMMUNICATION. THE CAMERA WAS NOT RESPONDING TO THE NAVIGATION SYSTEM PROPERLY. NO FURTHER DETAILS REGARDING THE BEHAVIOR, OR SPECIFICALLY WHEN IT OCCURRED, WERE PROVIDED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Patient Involvement

  MAUDE report 6308915 ↗