BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGN CART 9735665 STEALTH S8 PREMIUM

    MDR report key: 9167292 · Received October 8, 2019

    Report

    Report Number
    1723170-2019-05147
    Event Type
    Malfunction
    Date Received
    October 8, 2019
    Date of Event
    September 11, 2019
    Report Date
    November 21, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOGS AND ARCHIVE FOR THE NAVIGATION SYSTEM WERE REVIEWED BY MEDTRONIC PERSONNEL. HOWEVER, THE FILES PROVIDED NO ADDITIONAL INSIGHT INTO THE PROBABLE CAUSE OF THE ANOMALY. THE SOFTWARE INVESTIGATION FOUND THAT A PROBABLE CAUSE WAS UNABLE TO BE DETERMINED WITHOUT FURTHER INFORMATION SINCE THE ON-GOING INVESTIGATION PROVED TO BE INCONCLUSIVE BASED ON THE INFORMATION PROVIDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735737, SERIAL/LOT #: UNK. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT THE SURGEON EXPERIENCED A LOT OF DIFFICULTY REGISTERING THE PATIENT. WHEN THEY REGISTERED, IT TOOK A LONG TIME TO CALCULATE THE REGISTRATION ERROR METRIC. WHEN THEY FINALLY GOT THE ERROR METRIC UNDER 2.5 MM, THE SURGEON FELT THE NAVIGATION ACCURACY WAS OFF. THE SITE ENDED UP USING A NON MEDTRONIC NAVIGATION SYSTEM. THE REPRESENTATIVE NOTED THAT ONLY THE TRACER WAS OFF. IT WAS OFF ANATOMICALLY. THE POINT ON THE NOSE WAS SHOWING ON THE BACK OF THE HEAD. AT ONE POINT, THE REPRESENTATIVE COULD FOLLOW THE POINTER WHILE TRACING OVER THE HEAD, BUT IT WAS STILL INCORRECT WITH ORIENTATION. THEY NOTED IT WAS NOT AN ACCURACY ISSUE, BUT ORIENTATION ISSUE. THERE WAS A REPORTED DELAY OF LESS THAN ONE HOUR AND NO REPORTED IMPACT TO PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961891 SURGN CART 9735665 STEALTH S8 PREMIUM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR