BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYS 9734070R POLESTAR N30 REWORK

    MDR report key: 6153072 · Received December 7, 2016

    Report

    Report Number
    1723170-2016-05680
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    September 12, 2016
    Report Date
    February 9, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (ISRAEL)
    Product Code
    LNH
    PMA / PMN Number
    K092308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER AND WEIGHT WERE NOT MADE AVAILABLE FROM THE SITE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. THIS IS AN ISOLATED EVENT, THERE HAVE BEEN NO FURTHER ISSUES HAVE BEEN REPORTED. MEDTRONIC REPRESENTATIVE FOUND THE REPORTED ISSUE COULD NOT BE REPLICATED. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    PATIENT ID AND WEIGHT PROVIDED. CORRECTION TO SYSTEM SERIAL NUMBER, PART NUMBER AND UDI. MANUFACTURE TOOK PLACE PRIOR TO SEPT 17, 2009, BUT EXACT DAY IS NOT AVAILABLE. THE SYSTEM'S PROPER PERFORMANCE WAS VERIFIED DURING SURGERY COVERAGE. THIS IS AN ISOLATED EVENT. ANALYSIS OF THE LOG FILES FOR SURGERIES AT THE TIME OF THE REPORTED EVENT SHOW THAT THIS DIDN'T HAPPENED IN ANY OTHER SURGERIES. IN ADDITION, THIS COULD NOT BE REPRODUCED BY THE MANUFACTURER, AND DID NOT HAPPENED DURING THE SURGERIES THAT WERE COVERED BY A MEDTRONIC REPRESENTATIVE ON 7TH NOVEMBER AND 10TH NOVEMBER. UPDATE 10 JAN 2017: AFTER THOROUGH INVESTIGATION IT WAS DETERMINED THAT THE SOURCE OF THE INCORRECT REGISTRATION IS A RARE SYSTEM OPERATION SCENARIO THAT CAN BE EASILY AVOIDED. THIS SCENARIO PERTAINS ONLY TO THE STARSHIELD SYSTEM CONFIGURATION. ALTHOUGH THIS SITE HAS A SHIELDED ROOM, DUE TO A NON-STANDARD I7 INSTALLATION THE SITE WORKS IN A STARSHIELD REGIME. THE SYSTEM USER INTERFACE HAS A READY BUTTON THAT HAS TO BE PRESSED BEFORE IMAGING, AND THEN THE I7 NAVIGATION CAMERA IS SWITCHED OFF MANUALLY, ALONG WITH MOST OTHER DEVICES, THROUGH A DEDICATED POWER SWITCH. IT IS STRONGLY RECOMMENDED THAT THE SITE WILL COMPLETE THE STANDARD I7 INSTALLATION. THE USER WAS GIVEN INSTRUCTIONS ON HOW TO AVOID THIS PROBLEM, IN THE CURRENT SYSTEM CONFIGURATION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE RECEIVED A REPORT FROM A SITE ON 07-NOV-2016, THAT WHILE IN A CRANIAL PROCEDURE ON (B)(6) 2016, THE SURGEON ALLEGED A NAVIGATION ISSUE OCCURRED. AFTER ACQUIRING THE PRE-OPERATIVE SURGICAL MRI SYSTEM IMAGES AND LOWERING THE MAGNETS, THE SURGEONS SUCCESSFULLY NAVIGATED WITH THE PRE-OPERATIVE SURGICAL MRI SYSTEM IMAGES, RAISED THE OPERATING ROOM (O.R.) TABLE, AND PERFORMED THE TUMOR RESECTION. THEN THEY BROUGHT THE MAGNET BACK TO THE SCAN POSITION AND ACQUIRED NEW SETS OF IMAGES. THE NEW IMAGES WERE NOT CORRECTLY AUTO-REGISTERED, SO THAT NAVIGATION ON THEM AND COMPARING THEM WITH THE PRE-OPERATIVE IMAGES WAS OFF. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT CONFIRMATION IMAGE FROM SURGICAL MRI SYSTEM. DELAY IN THERAPY WAS LESS THAN ONE HOUR. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803128 SYS 9734070R POLESTAR N30 REWORK SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH MEDTRONIC NAVIGATION, INC. (ISRAEL)

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR