BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 2050933 · Received April 4, 2011

    Report

    Report Number
    1226348-2011-00125
    Event Type
    Injury
    Date Received
    April 4, 2011
    Manufacturer
    CODMAN AND SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    K914479
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THIS COMPLAINT HAS BEEN CONFIRMED. THE SUPPLIER PERFORMED THIS EVALUATION AND DURING THE EVALUATION A REVIEW OF THE QUALITY RECORDS WAS CONDUCTED AND PRIOR TO DISTRIBUTION THIS DEVICE MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS. THE CATHETER WAS EVALUATED AND THE FOLLOWING OBSERVATIONS NOTED: CATHETER HAS BEEN STRETCHED AND TORN AT CONNECTOR. WIRES ARE BROKEN INSIDE THE CATHETER. MULTIPLE KINKS AND BENDS ALONG CATHETER BODY. SUTURES TIED TO CATHETER BODY. TEAR IN SILASTIC STRAIN RELIEF AT CONNECTOR. UNABLE TO TEST. BASED ON THE ABOVE EVALUATION IT APPEARS THAT THE DEVICE WAS INADVERTENTLY DAMAGED BY THE CUSTOMER . NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    REP REPORTED THAT THE DEVICE STOPPED WORKING WHEN PLUGGED INTO THE GREY CABLE. IT DISPLAYED NO TRANSDUCER DETECTED. CABLE WAS CHANGED AND IT DID NOT WORK. PATIENT WAS TRANSPORTED TO A NEW HOSPITAL FOR A REVISION. IT WAS NOTED THAT THE DEVICE WAS IMBEDDED IN A HEMATOMA AND GEL FOAM, WHICH COULD HAVE BEEN THE PROBLEM. IT WAS ALSO NOTED THAT THE PATIENT WAS TRANSPORTED TO AND FROM CT 3 OR 4 TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROMONITOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN AND SHURTLEFF, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention