BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROSENSOR VENTRICULAR CATHETER KIT

    MDR report key: 2000779 · Received February 16, 2011

    Report

    Report Number
    1226348-2011-00063
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 24, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    GWM
    PMA / PMN Number
    K991222
    Removal / Correction Number
    NA
    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

    AFFILIATE REPORTED THAT AFTER IMPLANTATION THE SENSOR COULD NOT BE DETECTED. AS A RESULT THE DEVICE WAS REVISED AND WORKED FINE.

    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 425482

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK