BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN VPV SYSTEM

    MDR report key: 1161487 · Received September 15, 2008

    Report

    Report Number
    1226348-2008-00241
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC./MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    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 ACCORDING TO THE SURGEON THE PROGRAMMER DOES NOT WORK PROPERLY. IT HAPPENED VARIOUS TIMES THAT WHILE TRYING TO PROGRAM AN IMPLANTED HAKIM VALVE THE VPV APPROVED THAT PROGRAMMING HAS WORKED PROPERLY, BUT BY VERIFYING THIS WITH AN CT SCAN, IT SHOWED THAT THE PROGRAMMING HAD NOT WORKED. THE VALVE HAD NOT BEEN SET TO THE REQUESTED PRESSURE. IN ADDITION, THE DEVICE WOULD ONLY GIVE A CONFIRMATION OF COMPLETION WHEN PLACING THE PROGRAMMING HEAD DIRECTLY ONTO THE VALVE. ALSO, BY IMITATING HUMAN SKIN WITH A SILICONE MESH AND PLACING THE PROGRAMMING HEAD OVER THE SILICONE (BENEATH WHICH THE VALVE HAS BEEN PLACED), THE VPV GAVE NO CONFIRMATION ABOUT THE RESETTING. HOWEVER WHEN THE VALVE WAS CHECKED OPTICALLY, THE RESETTING HAD BEEN SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN VPV SYSTEM VALVE PROGRAMMER JXG CODMAN & SHURTLEFF, INC./MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK