NA 9734060 (UDI 00613994653482)Recalls & reported problems

Summary

The FDA's MAUDE database contains 208 adverse event reports that list this exact device (DI 00613994653482), received between Oct 30, 2016 and Jun 7, 2022 — classified as 7 injuries, 201 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (60 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 208 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2022Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED DURING A PROCEDURE. IT WAS REPORTED THAT THE ACCOUNT CLAIMS THAT DURING LONGER CASES ACCURACY DRIFTS. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14619770 ↗
• MalfunctionApr 8, 2021Display or Visual Feedback Problem; Human-Device Interface Problem; Application Program Freezes or Fails to Launch; Display or Visual Feedback Problem; Human-Device Interface Problem; Application Program Freezes or Fails to Launch

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THEY WERE ON SITE AND WERE ABLE TO GET THE SYSTEM TO POWER ON, BUT THE SOFTWARE AGAIN WAS MISSING THE EXAM INFORMATION AS IT REMAINED BLUE. IT WAS NOTED THAT THE SYSTEM WAS THEN POWERED DOWN AND THE COMPUTER NEVER RETURNED TO THE HOME SCREEN. A REPLACEMENT COMPUTER WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633487 ↗
• MalfunctionOct 1, 2020Connection Problem; Connection Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION BEING USED FOR CATHETER PLACEMENT PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS NOT WORKING. ADDITIONALLY, IT WAS STATED THEY WERE UNABLE TO GET THE SYSTEM TO RECOGNIZE THE AXIEM BOX OR EMITTER WAS CONNECTED. THEY DID NOT OPEN THE EMITTER DETAILS BUTTON, BUT THE EMITTER ICON IN THE BOTTOM RIGHT OF THE SCREEN HAD A RED X ON IT. AT THE SAME TIME THE AXIEM BOX ITSELF HAD GREEN STATUS LIGHTS. THEY TRIED ANOTHER AXIEM BOX AND EMITTER WITH NO RESOLUTION. THEY REBOOTED THE SYSTEM, AND WHEN IT CAME BACK UP IT WAS RUNNING MORE SLOWLY BUT WAS ABLE TO RECOGNIZE THE AXIEM. THERE WAS NO DELAY AND NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10613974 ↗
• MalfunctionJun 30, 2020Imprecision; Imprecision

  CONFIRMATION WITH THE MANUFACTURER REPRESENTATIVE THAT THE CASE WAS A TRIGEMINAL ACOUSTIC. THEY WERE USING CRANIAL SOFTWARE, USING OPTICAL NAVIGATION INSTRUMENTS "CHECKED".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10211738 ↗
• MalfunctionJun 17, 2020Computer Operating System Problem; Application Program Freezes or Fails to Launch; Computer Operating System Problem; Application Program Freezes or Fails to Launch

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS VERY SLOW TO BOOT UP AND WAS FREEZING WHILE IN THE APPLICATION. THE CLINICAL SPECIALIST (CS) HAD PREVIOUSLY DELETED PATIENT EXAMS AND REINSTALLED THE SOFTWARE. IT WAS REPORTED THAT THE SITE KEEPS THE SYSTEM ON 24/7 AD IT WAS BELIEVED THAT THE RACK ACTS THE SAME WAY. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 10162077 ↗
• MalfunctionJun 11, 2020Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE SYSTEM WAS BEING SET UP FOR A PROCEDURE, AND WHEN THEY GOT TO THE REGISTRATION SCREEN THE SOFTWARE EXITED TO THE "STEALTH" SCREEN. THE SYSTEM WAS THEN UNRESPONSIVE. THE SYSTEM WAS REBOOTED, AND THE SITE WAS ABLE TO COMPLETE THE PROCEDURE. SOFTWARE HAS ALREADY BEEN REINSTALLED, PATIENTS HAVE BEEN DELETED AND UNUSED RESOURCES HAVE BEEN REMOVED. THIS WAS REPORTED OUTSIDE OF A PROCEDURE. THERE WAS NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 10143433 ↗
• MalfunctionMay 26, 2020Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THERE WAS AN ALLEGED 5MM INACCURACY IN THEIR TRAJECTORY DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. THE SITE DID NOT WANT TO RE-SPIN AND PROCEEDED WITH THE INACCURACY. THERE WAS NO DELAY TO THE PROCEDURE AND NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10087735 ↗
• MalfunctionMay 21, 2020Mechanical Problem; Mechanical Problem

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE WAS RESOLVED BY UNINSTALLING AND REINSTALLING THE SOFTWARE. IT WAS NOTED THAT THE SYSTEM WAS USED TO COVER A CASE AND ALL WORKED WELL.

  Patient problems: No Patient Involvement

  MAUDE report 10079228 ↗
• MalfunctionApr 16, 2020Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED DURING A CRANIAL RESECTION. IT WAS REPORTED THAT THE CAMERA ON THE SYSTEM WAS NOT FUNCTIONING. THE SYSTEM WAS BEEPING BUT THE CAMERA WOULD NOT CONNECT. NAVIGATION WAS ABORTED AND THE SITE BROUGHT IN A DIFFERENT SYSTEM TO COMPLETE THE CASE. THERE WAS A PROCEDURE DELAY OF LESS THAN ONE HOUR AND NO IMPACT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9968697 ↗
• MalfunctionMar 30, 2020Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED DURING A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT PRIOR TO A CASE WHEN THE I7 WAS POWERED ON THE SOFTWARE DISPLAYED LOCALIZER NOT CONNECTED. THE SITE REBOOTED THE SYSTEM TWICE WITH NO CHANGE. THE LEDS ON THE CAMERA WERE GREEN. SITE CONTINUED CASE USING AXIEM. THERE WAS A DELAY OF LESS THAN 1 HOUR. NO PATIENT IMPACT WAS CORRELATED WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9896916 ↗
• MalfunctionMar 27, 2020Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR AN SPINE PROCEDURE. DURING THE PROCEDURE, THE INSTRUMENT TOOL CARDS COULD NOT BE ADDED INTO THE SOFTWARE AFTER INSTALLING SPINE TOOLS. THE MANUFACTURER REPRESENTATIVE CONFIRMED THE INSTRUMENT TOOLS DID NOT SHOW IN THE "INSTRUMENTS NOT AT THIS SITE" SECTION. REINSTALL OF THE TOOLS DATABASE DID NOT RESOLVE THE ISSUE. THE REPORTED ISSUE RESULTED IN APPROXIMATELY A 45 MINUTE PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED WITH THE USE OF ANOTHER NAVIGATION SYSTEM. FURTHER ACTIONS INCLUDED REQUESTING UNINSTALL/REINSTALL OF THE SPINE SOFTWARE. TO DATE, THIS HAD NOT BEEN COMPLETED.

  Patient problems: No Patient Involvement

  MAUDE report 9892334 ↗
• MalfunctionMar 4, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE MONITORS WERE INTERMITTENTLY GOING BLACK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 9787151 ↗
• MalfunctionFeb 25, 2020Communication or Transmission Problem; Communication or Transmission Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT BOTH OR TOUCH SCREENS ARE NOT WORKING. HE TRIED DOING A CALIBRATION BUT THE SCREENS DID NOT RESPOND AT ALL TO TOUCH. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9750869 ↗
• MalfunctionFeb 21, 2020Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THE SYSTEM SOFTWARE INDICATED THE LOCALIZER WAS NOT CONNECTED. THE SYSTEM WAS REBOOTED WITHOUT RESOLUTION.

  Patient problems: No Patient Involvement

  MAUDE report 9742369 ↗
• MalfunctionFeb 6, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM THAT WAS USED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT ONE OF THE BOOM MONITORS WAS FLICKERING AND A CLICKING NOISE COULD BE HEARD COMING FROM THE MONITORS. THE SITE WAS USING THE OPERATING ROOM WHERE THE SYSTEM IS INSTALLED IN BUT THE SYSTEM WAS NOT IN USE. IT WAS LATER REPORTED THAT THE SITE CALLED ABOUT MONITOR GOING BLACK AND NOT COMING BACK ON. IT WAS DETERMINED THAT THE TOUCHSCREEN IS UNRESPONSIVE TO TOUCH. NO PATIENT PRESENT.

  Patient problems: No Patient Involvement

  MAUDE report 9676077 ↗
• MalfunctionDec 31, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM USED DURING A THORACIC FUSION. IT WAS REPORTED THAT THE SYSTEM HAD A "LOCALIZER NOT CONNECTED" ERROR MESSAGE. THE SITE PRESSED THE NIU RESET BUTTON BUT THIS DID NOT RESOLVE THE ISSUE. SITE REBOOTED THE SYSTEM AND ISSUE RESOLVED. THERE WAS A DELAY OF LESS THAN 1 HOUR. NO PATIENT IMPACT WAS CORRELATED WITH THIS EVENT. ON 2019-DEC-30 INITIAL REPORTER (REP): NEW INFORMATION RECEIVED: PATIENT INFORMATION, SURGEON'S NAME AND SURGICAL PROCEDURE PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9534713 ↗
• MalfunctionDec 27, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE SYSTEM HAD A "LOCALIZER NOT CONNECTED" ERROR MESSAGE. THE SITE PRESSED THE NIU RESET BUTTON BUT THIS DID NOT RESOLVE THE ISSUE. THE SITE REBOOTED THE SYSTEM AND ISSUE RESOLVED. THERE WAS A DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO IMPACT TO THE PATIENT RELATED TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9527870 ↗
• MalfunctionDec 19, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED FOR A PROCEDURE. IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO LOGIN TO THE CRANIAL OR SPINE APPLICATIONS. IT WAS NOTED THAT IT SAT AT THE PARSING ELF SCREEN AND HAD BEEN THERE FOR MORE THAN 10 MINUTES. THE SITE SWITCHED TO ANOTHER NAVIGATION SYSTEM TO USE FOR THE UPCOMING CASE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9497592 ↗
• MalfunctionDec 10, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THE VGA PORT ON THE COMPUTER IN THE EQUIPMENT RACK WOULD NOT STAY FULLY SEATED, WHICH CAUSED INTERMITTENT VIDEO SIGNAL.

  Patient problems: No Patient Involvement

  MAUDE report 9442894 ↗
• MalfunctionDec 3, 2019Human-Device Interface Problem; Human-Device Interface Problem

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE IN A CRANIAL RESECTION, THE NAVIGATION SYSTEM DISPLAYED A "LOCALIZER NOT CONNECTED" MESSAGE. IT WAS REPORTED THAT THE CAMERA OF THE NAVIGATION SYSTEM WAS FULLY CONNECTED AND THAT THE LEDS FOR THE CAMERA WERE GREEN. IT WAS REPORTED THAT THE NAVIGATION INTERFACE UNIT (NIU) RESET BUTTON DID NOT RESTORE FUNCTIONALITY. IT WAS REPORTED THAT THE NAVIGATION SYSTEM WAS REBOOTED WHICH RESTORED FUNCTIONALITY. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF APPROXIMATELY 20 MINUTES DUE TO THIS ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9404695 ↗
• MalfunctionOct 11, 2019Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION THAT, WHILE IN A CRANIAL BIOPSY, A FIVE MILLIMETER ANTERIOR INACCURACY WAS OBSERVED AFTER PLACING THE STERILE FRAME ON. IT WAS NOTED THE ISSUE OCCURRED FOLLOWING A SUCCESSFUL PATIENT REGISTRATION THEN GOING STERILE FOR THE PROCEDURE. THE SITE BROKE STERILE, RE-REGISTERED AND WERE ABLE TO CONTINUE. 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9181164 ↗
• MalfunctionOct 1, 2019Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT WHILE NAVIGATING, THE IMAGES FLIPPED IN THE SOFTWARE AND NAVIGATION WAS OFF. NO OTHER DETAILS WERE PROVIDED. IMAGING WAS ABORTED CAUSING LESS THAN AN HOUR DELAY IN THE PROCEDURE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9140074 ↗
• MalfunctionSep 16, 2019Imprecision; Imprecision

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM BEING USED IN A CRANIAL RESECTION. IT WAS REPORTED THAT THE SYSTEM WAS INACCURATE 1CM DUE TO THE PATIENT REFERENCE FRAME MOVING. THE MANUFACTURER REPRESENTATIVE MENTIONED THE CHECKPOINTS FOR FUTURE REFERENCE. NAVIGATION WAS ABORTED CAUSING NO DELAY TO THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9070289 ↗
• MalfunctionAug 20, 2019Output Problem; Output Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL RESECTION PROCEDURE. THE ISSUE OCCURRED INTRAOPERATIVELY AND CAUSED NO DELAY TO THE SURGERY. IT WAS REPORTED THAT ONE OF THE NAVIGATION SYSTEM'S BOOM MONITORS WAS FLICKERING. THE SITE'S OTHER EXTERNAL MONITOR AND MEDTRONIC MONITORS WORKED WELL. THIS DID NOT AFFECT THE CASE SINCE THEY HAD OTHER MONITORS TO LOOK AT. TECHNICAL SERVICES (TS) HAD THE MEDTRONIC REPRESENTATIVE SWAP MONITORS AND THE WORKING MONITOR WORKED WITH THE OTHER CONNECTIONS. THE MEDTRONIC REPRESENTATIVE CONFIRMED THAT THE TWO VGA CABLES WERE DAMAGED WHERE THEY MEET AND FELL INTO THE RACK. THE SURGERY WAS COMPLETED WITH NAVIGATION AND THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8913026 ↗
• MalfunctionAug 19, 2019Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SPIN WAS NON-NAVIGATED BECAUSE THE SITE ALLOWED THE NON-NAVIGATED SPIN TO BE TRANSFERRED IN THE SOFTWARE. THE SECOND SPIN DID TRANSFER AUTOMATICALLY AND HAD A NAV TAG. ADDITIONAL INFORMATION WAS RECEIVED THAT THE SURGEON SAW THE BAR AT THE TOP OF THE ACQUIRE IMAGE TAB WAS RED NOT GREEN AND THE ERROR MESSAGE APPEARED ON THE PENDENT STATING THAT IT WOULD NOT BE A NAVIGATED SPIN. INSTEAD OF HITTING CANCEL, THE SITE HIT OK WHICH PRODUCED A NON-NAVIGATED SPIN. IT WAS ALSO FOUND THAT THE ETHERNET CABLE WAS FRAYED. IT WAS ALSO NOTED THAT THE SITE DRAPED THE IMAGING SYSTEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8906206 ↗