BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN VPV SYSTEM

    MDR report key: 2784141 · Received October 11, 2012

    Report

    Report Number
    1226348-2012-00500
    Event Type
    Injury
    Date Received
    October 11, 2012
    Manufacturer
    CODMAN AND SHURTLEFF - MEDOS
    Product Code
    JXG
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THIS COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE WAS VISUALLY AND FUNCTIONALLY TESTED AND WAS FOUND TO WORK IN ACCORDANCE WITH THE MANUFACTURING SPECIFICATIONS. THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTIONS. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Additional Manufacturer Narrative · 1

    THE 510K CODES: K061876 AND K050739.UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    REP REPORTED THAT THE PATIENT ORIGINALLY HAD THE SHUNT PUT IN (B)(6) 2009. HE HAD AN MRI ON (B)(6) 2012. THE VALVE WAS SUPPOSED TO BE SET AT 170MM H2O. THEY COULDN'T REPROGRAM IT AFTER THE MRI. 5 HOURS LATER THE PATIENT HAD HEADACHES, VOMITING AND LETHARGY. THEY REPROGRAMMED THE VALVE WITH ANOTHER PROGRAM ON TUESDAY BUT, DID A REVISION ON WEDNESDAY. THEY FOUND THAT THE CATHETER WAS BLOCKED. HOWEVER, EVEN THE VENTRICLES WERE SMALL TO BEGIN WITH, THEY WERE SMALLER AFTER THIS INCIDENT. THE VALVE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN VPV SYSTEM VALVE PROGRAMMER JXG CODMAN AND SHURTLEFF - MEDOS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention