BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO VENTRICULAR BOLT ICP / TEMPERATURE MONITOR

    MDR report key: 2894437 · Received December 27, 2012

    Report

    Report Number
    2023988-2012-00049
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    INTEGRA NEURO SCIENCES CA/USA
    Product Code
    GWM
    PMA / PMN Number
    K962928
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    INTEGRA RECEIVED A REPORT REGARDING A 1104 HMT MICRO VENTRICULAR BOLT INTRACRANIAL PRESSURE - TEMPERATURE MONITOR CATHETER, WHICH "STOPPED WORKING AFTER 4 DAYS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO VENTRICULAR BOLT ICP / TEMPERATURE MONITOR NA GWM INTEGRA NEURO SCIENCES CA/USA 3050RX208491

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR