BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO VENTRICULAR BOLT ICP/TEMPERATURE MONITOR

    MDR report key: 3874557 · Received April 22, 2014

    Report

    Report Number
    2023988-2014-00015
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 28, 2014
    Manufacturer
    INTEGRA NEUROSCIENCES 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 INFORMATION

    Description of Event or Problem · 1

    A 1104 HMT MICRO VENTRICULAR BOLT (ICP) INTRACRANIAL PRESSURE WAS ZEROED AND INSERTED INTO THE PATIENTS HEAD FOR DECOMPRESSIVE SURGERY FOLLOWING A HEAD INJURY. THE SURGEON CONNECTED THE PAC1 BUT IT WAS IMPOSSIBLE TO MEASURE. ANOTHER 1104 HMT CATHETER WAS AVAILABLE FOR USE. IT WAS INSERTED AND IT FUNCTIONED PROPERLY. THE PATIENT DID NOT INCUR AN INJURY AS A RESULT OF THIS EVENT OR BECAUSE OF THE 5 MINUTE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242912 MICRO VENTRICULAR BOLT ICP/TEMPERATURE MONITOR NA GWM INTEGRA NEUROSCIENCES CA/USA

    Patients

    Seq Age Sex Outcome Treatment
    1