BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 1915262 · Received November 2, 2010

    Report

    Report Number
    1723170-2010-00070
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. INVESTIGATION OF DEVICE HAD NOT BEEN COMPLETED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    SITE REP REPORTED THAT THE TRACER FAILED DURING A CRANIAL SURGERY. SURGERY CONTINUED BUT USE OF THE MEDTRONIC STEALTHSTATION S7 SYSTEM WAS ABORTED. THE SURGEON CONTINUED AND COMPLETED THE CASE. THERE WAS NO IMPACT ON THE PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION S7 SYSTEM STEREOTAXIC SYSTEM (HAW) HAW MEDTRONIC NAVIGATION S7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK