BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 850327 · Received May 15, 2007

    Report

    Report Number
    1226348-2007-00142
    Event Type
    Injury
    Date Received
    May 15, 2007
    Date of Event
    March 1, 2007
    Manufacturer
    CODMAN & SHURTLEFF, INC/MEDOS S.A
    Product Code
    GWM
    PMA / PMN Number
    K914479
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THIS COMPLAINT COULD NOT BE CONFIRMED. THE SUPPLIER PERFORMED THIS EVALUATION. DURING THE EVALUATION, A REVIEW OF QUALITY RECORDS WAS CONDUCTED AND PRIOR TO DISTRIBUTION, THIS DEVICE MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS. THE CATHETER WAS ALSO EVALUATED AND THE FOLLOWING OBSERVATIONS NOTED: 1. THE PRESSURE SENSOR IS UNDAMAGED. 2. THE CATHETER MATERIAL IS PINCHED/KINKED 6CM AND 57CM FROM THE TIP. 3. THERE ARE MULTIPLE BENDS ALONG THE CATHETER LENGTH. 4. THE UNIT PASSED ALL TESTS. BASED ON THE ABOVE EVALUATION, THE SUPPLIER WAS UNABLE TO VERIFY THE COMPLAINT. SINCE THIS COMPLAINT COULD NOT BE CONFIRMED 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

    AFFILIATE REPORTED THAT THE PATIENT WAS ACUTE FOR SDH, EDH AND REVIEW OF A SKULL FRACTURE. THE PATIENT RECEIVED A CODMAN ICP EXPRESS AND MICRO DIALYSIS. AFTER THE OPERATION ,THE ICP INCREASED TO 50-60 MMHG, WHICH CAUSED A TREATMENT WITH SALINE AND "PENTOLHAINATRIUM" WITHOUT EFFECTS. A CT SCAN WAS OK AND THERE WAS NO EXPLANATION FOR THE HIGH ICP VALUE. THE MICRO DIALYSIS VALUE WAS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROMONITOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC/MEDOS S.A NA 319496

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention