BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROG VALVE INLINE SIPHONGUARD

    MDR report key: 2243478 · Received September 12, 2011

    Report

    Report Number
    1226348-2011-00342
    Event Type
    Injury
    Date Received
    September 12, 2011
    Manufacturer
    CODMAN AND SHURTLEFF - MEDOS
    Product Code
    JXG
    PMA / PMN Number
    K992173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE NEEDLE CHAMBER OF THE VALVE WAS DAMAGED. THERE WAS EVIDENCE OF SCALPEL DAMAGE ON BOTH THE TOP AND BOTTOM OF THE DEVICE. IT MIGHT ALSO BE POSSIBLE THAT WHEN THE VALVE WAS EX-PLANTED, THAT IS WHEN THE BASE OF THE NEEDLE CHAMBER AND THE PROXIMAL CONNECTOR WAS DETACHED. THIS HOWEVER COULD NOT BE CONFIRMED. IT WAS ALSO NOTED THAT DUE TO THE CONDITION OF THE DEVICE IT WAS NOT POSSIBLE TO CONDUCT IRRIGATION OR PRESSURE TESTING. THE VALVE DID HOWEVER PASS THE PROGRAMMING TEST. THE ROOT CAUSE FOR THE CONDITION OF THIS DEVICE COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THE 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.

    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 IT WAS FOUND THAT FLUID DID NOT FLOW THROUGH THE DEVICE AND REQUIRED REMOVAL OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM PROG VALVE INLINE SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM COMPS JXG CODMAN AND SHURTLEFF - MEDOS CKHCRH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention