BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGR. VALVE

    MDR report key: 1082977 · Received July 28, 2008

    Report

    Report Number
    1226348-2008-00195
    Event Type
    Injury
    Date Received
    July 28, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC./MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    NA
    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

    AFFILIATE REPORTED THAT A CHILD BORN IN 2008 RECEIVED A MICRO VALVE ABOUT 33 DAYS LATER, THAT WAS SET AT 50MMHG. A REVISION WAS NECESSARY ABOUT 2 MONTHS LATER DUE TO AN MRI THAT SHOWED VENTRICULAR EXPANSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGR. VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC./MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention