BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 1922601 · Received November 19, 2010

    Report

    Report Number
    1723170-2010-00090
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    MEDTRONIC NAVIGATION
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION REQUIRED AS THE EVENT DID NOT OCCUR DURING SURGERY. THE RETURNED PRODUCT DID NOT MEET SPECIFICATIONS. THE DEVICE MALFUNCTION WAS CONFIRMED AND DIRECTLY RELATED TO THE REPORTED EVENT. A REPLACEMENT PART WAS SENT TO THE SITE AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE POSITIONING SENSOR UNIT ON THE S7 WAS CYCLING. REP SAID IT WAS WORKING PROPERLY FOR A WHILE TO COMPLETE A MICROSCOPE CALIBRATION AND THEN AFTER REBOOTING, THE CYCLING HAPPENED AGAIN. THERE WAS NO PATIENT PRESENT.

    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 NONE