BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S7 STAFF ASSEMBLED 110V

    MDR report key: 8665210 · Received June 3, 2019

    Report

    Report Number
    1723170-2019-02898
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Report Date
    June 3, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9733686, SERIAL/LOT #: UNKNOWN. ANALYSIS OF THE 9733856 FOUND INSUFFICIENT INFORMATION. ANALYSIS OF THE 9733686 FOUND INSUFFICIENT INFORMATION. UNABLE TO DETERMINE PROBABLE CAUSE WITHOUT FURTHER INFORMATION SINCE THE BEHAVIOR CANNOT BE REPLICATED. 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 SYSTEM WHILE IN A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE FIRST SPIN WAS OFF BY ABOUT A CENTIMETER POSTERIOR. SITE WERE USING E-Z STERILE WRAP AROUND THE PATIENT DRAPE. SITE NOTICED IT WAS OFF AFTER THE FIRST SPINS AND RE-DRAPRED THE PATIENT WITH THE SAME DRAPE AND ANOTHER SPIN WAS PERFORMED. A SECOND SPIN VERIFIED THE ACCURACY. THE PROCEDURE WAS COMPETED WITH THE USE OF NAVIGATION. THERE WAS A DELAY OF 10 MINUTES. NO KNOWN IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458450 S7 STAFF ASSEMBLED 110V INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1