BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAVITY COMPENSATING ACCESSORY (GCA)

    MDR report key: 408174 · Received August 1, 2002

    Report

    Report Number
    9612007-2002-00012
    Event Type
    Injury
    Date Received
    August 1, 2002
    Date of Event
    June 7, 2002
    Manufacturer
    NMT NEUROSCIENCES IMPLANTS S.A.
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A REPORT FROM THE FIELD INDICATED THAT A PT DEVELOPED SLIT VENTRICLES SYNDROME 5 DAYS AFTER IMPLANTATION OF PHOENIX ANTIBLOCK CATHETER CONNECTED TO AN OSV II. THE SURGEON SUBSEQUENTLY CONNECTED A GCA BUT THE SYMPTOMS CONTINUE. HE LATER INDICATED THAT HE HAD REVISED THE OSV/GCA AND REPLACED IT WITH AN OSV II. HE INDICATED HE DID NOT CONSIDER THIS IS A COMPLAINT, AND DURING THE VALVE REVISION HE NOTED A DURAL LEAK WHICH HE REPAIRED. THE PT IS DOING WELL SINCE THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAVITY COMPENSATING ACCESSORY (GCA) HYDROCEPHALUS VALVE COMPONENT JXG NMT NEUROSCIENCES IMPLANTS S.A. NA 114817

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention