BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 2553269 · Received April 30, 2012

    Report

    Report Number
    1226348-2012-00217
    Event Type
    Injury
    Date Received
    April 30, 2012
    Date of Event
    January 16, 2012
    Manufacturer
    CODMAN AND SHURTLEFF - MEDOS
    Product Code
    JXG
    PMA / PMN Number
    K974739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    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 DEVICE RETURNED WAS FOUND TO BE THAT OF 82-3100 AND NOT 82-3110 AS PREVIOUSLY REPORTED BY THE CUSTOMER. IT WAS VERIFIED THAT THE STATOR WAS DISLODGED THEREFORE; THE CAM POSITION/PRESSURE COULD NOT BE DETERMINED. UPON FURTHER INVESTIGATION IT WAS REVEALED THAT NO OTHER DAMAGE WAS NOTED. ENHANCEMENTS WERE INTRODUCED TO THIS DEVICE, WHICH WAS DESIGNED TO ADD A WALL THICKNESS TO MINIMIZE THIS TYPE OF DISLODGEMENT. IT WAS NOTED THAT THIS DEVICE WAS MANUFACTURED PRIOR TO THE ENHANCEMENTS. A REVIEW OF THE LOT HISTORY RECORDS CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION. 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

    AFFILIATE REPORTED THAT A MRI CONFIRMED A PART OF THE VALVE WAS DISPLACED. IT IS NOT CLEAR WHAT PART. AS A RESULT THE DEVICE WAS REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM COMPS JXG CODMAN AND SHURTLEFF - MEDOS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention