BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAVITY COMPENSATING ACCESSORIES BROWN, HIGH

    MDR report key: 1011298 · Received March 11, 2008

    Report

    Report Number
    9612007-2008-00009
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 11, 2008
    Report Date
    March 6, 2008
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION, AND HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. [SEE SCANNED PAGES].

    Description of Event or Problem · 1

    THE GRAVITY COMPENSATING ACCESSORY (GCA) DEVICE WAS IMPLANTED IN 2008. THE GCA WAS CONNECTED TO A DELTA VALVE THAT IS MADE BY PS MEDICAL. THIS DELTA VALVE WAS IMPLANTED IN 1995. POSTOPERATIVELY, THE PHYSICIAN QUESTIONED IF THE GCA WAS CONNECTED PROPERLY TO THE DELTA VALVE AND IF THERE WAS A POSSIBILITY THE CONNECTION OF THE TWO DEVICES WERE LEAKING. IN 2008, THE PHYSICIAN DECIDED TO REMOVE THE GCA AND REVISED THE GCA DEVICE TO A MEDIUM PRESSURE GCA. THE EXPLANTED GCA IS AVAILABLE, AND EXPECTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAVITY COMPENSATING ACCESSORIES BROWN, HIGH VALVE ACESSORIES JXG INTEGRA NEUROSCIENCES IMPLANTS S.A. 0145917

    Patients

    Seq Age Sex Outcome Treatment
    1