BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM IN LINE PROGRAMMABLE VALVE

    MDR report key: 2010755 · Received March 2, 2011

    Report

    Report Number
    1226348-2011-00077
    Event Type
    Injury
    Date Received
    March 2, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC., MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K974739
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVAL. WITHOUT THE DEVICE, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED, A REVIEW OF THE MFG RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVAL WILL REVEAL THAT THE DEVICE CONFORMED TO SPECS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND, THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT, THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A F/U REPORT WILL FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT APPROXIMATELY FIVE YEARS AFTER THE PT RECEIVED A VALVE, IT WAS REVISED SINCE THE PT WAS NOT FEELING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention