BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE W/ PRECHAMBER

    MDR report key: 3404699 · Received October 10, 2013

    Report

    Report Number
    1226348-2013-29577
    Event Type
    Injury
    Date Received
    October 10, 2013
    Date of Event
    September 11, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE PRODUCT CODE IS NS-9008 NOT 82-3110 AND THE LOT NUMBER IS CLBCHZ NOT CGGBPR AS PREVIOUSLY REPORTED. VISUAL EXAMINATION REVEALED THAT THE STATOR WAS DISLODGED AND THEREFORE THE CAM POSITION / PRESSURE COULD NOT BE DETERMINED. FURTHER INVESTIGATION NOTED THAT THE VALVE CASING WAS CRACKED. IT MIGHT BE LIKELY THAT THE DEVICE SUSTAINED SOME FORM OF IMPACT CAUSING THE CRACKED CONDITION OF THE DEVICE. THIS HOWEVER COULD NOT BE CONFIRMED. A REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE CONFORMED TO THE REQUIRED SPECIFICATIONS WHEN RELEASED TO STOCK. 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.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT THE VALVE WAS DESTROYED DURING MRI. AS A RESULT, THE DEVICE WAS REVISED. NO DAMAGE TO THE PATIENT. ADDITIONAL INFORMATION IS EXPECTED TO EXPLAIN THE TERM, "DESTROYED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515775 HAKIM PROGRAMMABLE VALVE W/ PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CLBCHZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention