BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 1842050 · Received September 21, 2010

    Report

    Report Number
    1226348-2010-00299
    Event Type
    Injury
    Date Received
    September 21, 2010
    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 Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A MESSAGE DISPLAYED ON THE ICP EXPRESS UNIT SCREEN THAT "NO TRANSDUCER DETECTED". ADD'L INFO RECEIVED REVEALED THAT ONE OF MICROSENSORS (82-6631) WAS IMPLANTED AND EXPLANTED ON THE FOLLOWING DAY. THE 2ND MICROSENSOR WITH CATHETER (82-6653) WAS OPENED BUT NEVER USED, AND WAS DISPOSED OF BY THE HOSPITAL. IT WAS ALSO NOTED THAT THE DR BELIEVES THAT THE PROBLEM WAS WITH THE ICP EXPRESS CABLE.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 82-6653| 82-6636