BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 2161933 · Received July 11, 2011

    Report

    Report Number
    1226348-2011-00260
    Event Type
    Injury
    Date Received
    July 11, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT CLEAR AT THIS POINT IF THE DEVICE AND/OR LOT INFORMATION IS AVAILABLE. WITHOUT THE DEVICE AND/OR LOT INFORMATION, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF THE DEVICE IS RETURNED, THE COMPLAINT WILL BE INVESTIGATED AND A FOLLOW UP REPORT WILL BE FILED. IF LOT INFORMATION DOES BECOMES AVAILABLE AND IF THE RECORD REVIEW INDICATES THAT THERE WAS A NON-CONFORMITY, A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    AFTER PERSISTENT HEADACHES, EXPLORATORY SURGERY TO EVALUATE THE SHUNT WAS CARRIED OUT. SURGEON NOTED THAT THE CONNECTION OF THE VENTRICULAR CATHETER TO THE CHPV WAS NOT SECURE AND WAS LEAKING. IT IS NOT CLEAR IF A NEW CATHETER WAS IMPLANTED OR NOT.

    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 23 YR Required Intervention