BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO VENTRICULAR BOLT ICP MONITORING KIT

    MDR report key: 2109803 · Received May 18, 2011

    Report

    Report Number
    2023988-2011-00012
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 10, 2011
    Report Date
    May 18, 2011
    Manufacturer
    INTEGRA
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 REPORT WAS RECEIVED INVOLVING A 1104 HM-OLM INTRACRANIAL MONITORING PRESSURE KIT WHICH WAS DESCRIBED AS FOLLOWS; THE UNIT DID NOT SHOW A SIGNAL ON THE SCREEN WHEN THE CATHETER WAS CONNECTED TO THE PAC CABLE. THERE WAS NO PATIENT CONTACT; HOWEVER, SURGERY WAS DELAYED FOR 30 MINUTES. ANOTHER CATHETER WAS USED AND THE CAMINO WORKED PROPERLY. IT IS UNKNOWN WHETHER THE PATIENT WAS ANESTHETIZED WHILE THE UNIT WAS BEING CHANGED. FURTHER INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO VENTRICULAR BOLT ICP MONITORING KIT N/A GWM INTEGRA 3050RY173347

    Patients

    Seq Age Sex Outcome Treatment
    1