BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRG INLIN ASD PLATFORM VO

    MDR report key: 2120235 · Received June 7, 2011

    Report

    Report Number
    1226348-2011-00206
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    May 11, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC., MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K053350
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    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

    REP REPORTED THAT A SHUNT REVISION WAS PERFORMED ON A PT BELIEVED TO HAVE A FAILURE IN THE SHUNT SYSTEM. IT WAS DISCOVERED THAT THE VALVE WAS NOT DRAINING. FLOW WAS OBSERVED WITH THE VENTRICULAR CATHETER AND A MANOMETER WAS USED TO TEST THE DISTAL CATHETER, WHICH WAS PATENT. A MANOMETER WAS USED TO TEST THE VALVE AND FLOW WAS NOT OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRG INLIN ASD PLATFORM VO SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC., MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention