BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYLINDRICAL CHPV

    MDR report key: 5785470 · Received July 12, 2016

    Report

    Report Number
    1226348-2016-10502
    Event Type
    Injury
    Date Received
    July 12, 2016
    Date of Event
    June 25, 2016
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED UDI: GTIN UNAVAILABLE, PRODUCT CODE UNKNOWN; (17)091130(11)050121(10)1263009(21) PCD727 DEVICE EVALUATION: D4, G4, G7, H2, H3, H4, H6, H10. UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE VALVE WAS VISUALLY INSPECTED IT WAS NOTED THAT THE STATOR AND THE X RAY DOT WERE DISLODGED. THEREFORE, THE CAM POSITION/PRESSURE COULD NOT BE DETERMINED. THE VALVE WAS HYDRATED FOR 24 HOURS. THE VALVE WAS FLUSHED, THE VALVE PASSED THE TEST NO OCCLUSION WAS NOTED. THE VALVE WAS LEAK TESTED; NO LEAKS WERE NOTED. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: A SCRATCH MARK AND A CRACK IN THE VALVE CASING WERE NOTED. THIS IS PROBABLY DUE TO THE VALVE RECEIVING SOME FORM OF IMPACT. CORROSION WAS NOTED ON THE STATOR AND THE X RAY DOT. THE CAM MAGNETS WERE CONTROLLED. THE MAGNETS PASSED. THE LOT HISTORY RECORD WAS REVIEWED FOR COMPLETENESS DURING THE RELEASE PROCESS TO INVENTORY. AT THAT TIME BASED ON THE FACT THAT NO DISCREPANCIES WERE NOTED FOR THE PRODUCTS BEING ACCEPTED, THEY WERE RELEASED TO STOCK ON THE 21ST JANUARY 2005. THE ROOT CAUSE OF THE CORROSION COULD NOT BE CLEARLY DETERMINED. THE ROOT CAUSE FOR THE DISLODGED STATOR AND X RAY DOT COULD BE PARTLY DUE TO THE VALVE RECEIVING A SOME FORM OF IMPACT, AS WELL AS THE CORROSION. 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 · 0

    THE DEVICE HAS BEEN RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CAM OF THE VALVE BECAME UNSEATED. A LARGE "X" CAN BE SEEN ON THE CT SCAN WHICH SHOWED THE VALVE BECAME UNSEATED. THE CLINICIAN REPLACED THE VALVE. PER REP:"I WAS MADE AWARE LAST FRIDAY, (B)(6). THE VALVE WAS EXPLANTED ON (B)(6)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441683 CYLINDRICAL CHPV SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG 1263009

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention