BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POST CRANIOTOMY SUBDURAL ICP MONITORING

    MDR report key: 510174 · Received January 14, 2004

    Report

    Report Number
    2023988-2004-00011
    Event Type
    Malfunction
    Date Received
    January 14, 2004
    Date of Event
    December 7, 2003
    Report Date
    January 14, 2004
    Manufacturer
    INTEGRA NEUROCARE LLC
    Product Code
    GWM
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HEAD INJURY PT WAS BEING MONITORED FOR INTRACRANIAL PRESSURE USING A 110-4G CATHETER. THE CATHETER READ 60 MMHG TO 16 MMHG, WHICH WAS NOT STABLE. NO FURTHER INFO WAS AVAILABLE. ADDITIONAL INFO WAS REQUESTED ON DEC. 22, 2003. ADDITIONAL INFO WAS RECEIVED, THE CATHETER WAS PLACED AND APPROX. 5 TO 8 MINUTES POST INSERTION, THE READINGS WERE UNSTABLE. AN EXTERNAL TRANSDUCER WAS NOT USED. THE CATHETER WAS REPLACED AND ICP MONITORING CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POST CRANIOTOMY SUBDURAL ICP MONITORING NEURO MONITORING GWM INTEGRA NEUROCARE LLC * W049211

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN