BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA VALVE

    MDR report key: 192565 · Received October 7, 1998

    Report

    Report Number
    2021898-1998-00112
    Event Type
    Malfunction
    Date Received
    October 7, 1998
    Report Date
    September 8, 1998
    Manufacturer
    MEDTRONIC PS MEDICAL
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHEN DR EXPLANTED DELTA VALVES (FOR REASON OTHER THAN VALVE PROBLEM), HE DISCOVERED A LEAK IN THE DELTA CHAMBER. IT WAS LATER DISCOVERED THAT THE LEAKAGE WAS DUE TO HIS EXPLANTATION TECHNIQUE. (MFR. REPORT #2021898-1998-00112-00114).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA VALVE Implant CENTRAL NERVOUS SYSTEM FLUID SHUNTS AND COMPONENTS JXG MEDTRONIC PS MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN