BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO VENTRICULAR BOLT

    MDR report key: 529517 · Received March 1, 2004

    Report

    Report Number
    2023988-2004-00019
    Event Type
    Malfunction
    Date Received
    March 1, 2004
    Report Date
    March 1, 2004
    Manufacturer
    INTEGRA NEUROCARE LLC
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SALES REP REPORTED THAT CEREBROSPINAL FLUID WAS LEAKING OUT OF THE BOLT. NO PT INJURY HAS BEEN REPORTED. THIS REPORTED INCIDENT HAS OCCURRED WITH MULTIPLE PTS. THE DEVICES WERE REPLACED. IN ONE INCIDENT THE REPLACEMENT FUNCTIONED AS DESIRED. WITH ANOTHER PT THE REPLACED DEVICE STILL LEAKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO VENTRICULAR BOLT NEURO MONITORING GWM INTEGRA NEUROCARE LLC * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *