BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO VALVE, NO CATHETERS 18 SET 30-200MM H20

    MDR report key: 4018014 · Received August 18, 2014

    Report

    Report Number
    1226348-2014-11907
    Event Type
    Injury
    Date Received
    August 18, 2014
    Product Code
    JXG
    PMA / PMN Number
    PK980778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).VISUAL EXAMINATION OF THE VALVE REVEALED THAT THE STATOR WAS DISLODGED. THEREFORE; THE CAM POSITION/PRESSURE COULD NOT BE DETERMINED. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: IT WAS NOTED THAT THE VALVE CASING WAS CRACKED, AND A BUMP MARK FROM THE CAM MECHANISM WAS FOUND IN THE VALVE CASING, THIS IS DUE TO THE VALVE SUSTAINING SOME FORM OF IMPACT. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3112 WITH LOT CJCB5W CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 11TH MARCH 2008. THE ROOT CAUSE OF THE DISLODGEMENT IS DUE TO THE VALVE RECEIVING A HARD KNOCK. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    AT THE PRESENT TIME, THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    NO GTIN NUMBER AVAILABLE. UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ROTOR DISLOCATED FROM BASEPLATE; PROGRAMMING OF THE VALVE NOT POSSIBLE. VALVE WAS EXPLANTED AND EXCHANGED WITH SAME LIKE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494652 MICRO VALVE, NO CATHETERS 18 SET 30-200MM H20 SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CJCB5W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention