INSTRUMENT, STEREOTAXIC

Additional Manufacturer Narrative

PATIENT INFORMATION NOT AVAILABLE. DEVICE INFORMATION NOT AVAILABLE ON THE DATE OF FILING. NO DEVICE/COMPONENTS WERE RETURNED TO THE MANUFACTURER ON THE DATE OF FILING. MANUFACTURE DATE WAS NOT AVAILABLE ON THE DATE OF FILING. PMA/510(K) NUMBER WAS NOT AVAILABLE ON THE DATE OF FILING. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT INTRA/PERI-OPERATIVELY DURING A CRANIAL RESECTION PROCEDURE, REGISTRATION WAS PERFORMED WITH PRONE POSITION IN EM FOR THE CRANIOTOMY PROCEDURE OF TUMOR EXCISION, BUT THE ACCURACY WAS UNFAVORABLE. THUS, RESTARTING REGISTRATION WAS ATTEMPTED BY PRESSING THE ANTENNA AGAINST ANOTHER PLACE, BUT BOTH THE ANTENNA AND THE PROBE BECAME UNABLE TO RESPOND. THE ISSUE PERSISTED DESPITE REBOOTING. THE ORANGE ERROR LAMP LIT UP ON THE BOX OF EM. THE ISSUE WAS RESOLVED BY SWITCHING TO OPTICAL. THERE WAS A DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

Additional Manufacturer Narrative

THE COMPUTER WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE COMPUTER PASSED ALL FUNCTIONAL TESTS. IT WAS DETERMINED THERE WAS LOOSE CONNECTION. THE AMBER LED ON THE AXIEM CONTROLLER WAS DETERMINED TO MOST LIKELY NOT BE CAUSED BY COMPUTER POWER CYCLING ON ITS OWN. LOOSE CONNECTION CONFIRMED. THE AXIEM CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND THAT AFTER LEAVING THE UNIT CONNECTED FOR A SHORT TIME, A RED STATUS/ERROR WAS DISPLAYED. EMINTERFACE SHOWED FAULTS ON ALL DRIVES. ANALYSIS FOUND THAT THE REPORTED EVENT WAS RELATED TO AN ELECTRICAL ISSUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative

A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE NAVIGATION SYSTEM AND CONFIRMED THE REPORTED ISSUE. PARTS WERE REPLACED AND THE SYSTEM IS WORKING AS INTENDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT INTRA/PERI-OPERATIVELY DURING A CRANIAL RESECTION PROCEDURE THAT REGISTRATION WAS PERFORMED WITH PRONE POSITION IN EM FOR THE CRANIOTOMY PROCEDURE OF TUMOR EXCISION, BUT THE ACCURACY WAS UNFAVORABLE. THUS, RESTARTING REGISTRATION WAS ATTEMPTED BY PRESSING THE ANTENNA AGAINST ANOTHER PLACE, BUT BOTH THE ANTENNA AND THE PROBE BECAME UNABLE TO RESPOND. THE ISSUE PERSISTED DESPITE REBOOTING. THE ORANGE ERROR LAMP LIT UP ON THE BOX OF EM. THE ISSUE WAS RESOLVED BY SWITCHING TO OPTICAL. THERE WAS A DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

Additional Manufacturer Narrative

CORRECTION - THE LOT NUMBERS OF THE RETURNED AXIEM CONTROLLER AND COMPUTER ARE AVAILABLE: AXIEM CONTROLLER: 0200057203 COMPUTER: 2020686. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.