BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROSENSOR VENTRICULAR CATHETER KIT

    MDR report key: 636302 · Received September 21, 2005

    Report

    Report Number
    1226348-2005-00219
    Event Type
    Injury
    Date Received
    September 21, 2005
    Date of Event
    August 23, 2005
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE MICROSENSOR VENTRICULAR CATHETER WAS REPLACED AFTER 12 HOURS BECAUSE OF LEAKAGE. CUSTOMER WAS CONTACTED. THE DEVICE WAS IMPLANTED BEFORE 7 PM IN 08/2005. IT WORKED FINE UNTIL ABOUT 7 AM NEXT DAY. CUSTOMER REPORTS THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSENSOR VENTRICULAR CATHETER KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC. NA FX231

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention