BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE, RT ANGLE

    MDR report key: 2191233 · Received July 29, 2011

    Report

    Report Number
    1226348-2011-00283
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 1, 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
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE VALVE DETERMINED THAT BIOLOGICAL DEBRIS WITHIN THE DEVICE LIKELY CAUSED THE DIFFICULTY EXPERIENCED BY THE CUSTOMER. THIS BIOLOGICAL DEBRIS WAS DISLODGED DURING FLOW TESTING OF THE RETURNED VALVE. AFTER DISLODGING, THE VALVE PASSED THE PROGRAMMING AND PRESSURE TESTS. IT WAS ALSO NOTED THAT THE SILICONE HOUSE WAS CUT WITH WHAT APPEARS TO BE SCALPEL MARKS. IT IS NOT POSSIBLE TO DETERMINE IF THIS OCCURRED DURING THE IMPLANT OR EX-PLANT OF THE DEVICE. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE VALVE MET SPECIFICATIONS WHEN RELEASED TO STOCK. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    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 THE DEVICE WAS REVISED AS IT STOPPED FUNCTIONING AFTER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM PROGRAMMABLE VALVE, RT ANGLE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. MEDOS S.A. NA CLHB5R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention (B)(4)