BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 1172092 · Received September 23, 2008

    Report

    Report Number
    1226348-2008-00244
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    July 19, 2008
    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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THE DEVICE WAS INSERTED INTO PT AND REPLACED WITH A NEW MICROSENSOR 224 HOURS LATER. MICROSENSOR WOULD NOT COMMUNICATE WITH THE ICP MONITOR.

    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 CHMC2W

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention