BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROSENSOR VENTRICULAR CATHETER KIT

    MDR report key: 1870405 · Received October 11, 2010

    Report

    Report Number
    1226348-2010-00332
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 13, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GWM
    PMA / PMN Number
    K991222
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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

    THE SURGEON HAS REPORTED THAT THE PRODUCT IS FAULTY AS THE ICP SENSOR WOULD NOT RECORD A READING. AS A RESULT, THE SURGEON REMOVED THE FAULTY CATHETER AND IMPLANTED A NEW VENTRICULAR CATHETER KIT.

    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 JA302

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention