BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 1885042 · Received October 20, 2010

    Report

    Report Number
    1226348-2010-00347
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    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 Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFO IS NOT AVAILABLE FOR EVAL. WITHOUT THE DEVICE AND/OR LOT INFO, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT, THE DEVICE AND/OR LOT INFO DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE 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

    AFFILIATE REPORTED THAT THE STEPPING MOTOR DETACHED FROM THE BASE PLATE. THERE WERE NO ADVERSE CONSEQUENCES, AND A REVISION WAS NOT PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK