BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPORE

    MDR report key: 3961711 · Received July 28, 2014

    Report

    Report Number
    2124215-2014-14539
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    DTB
    PMA / PMN Number
    K883602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE CHANGE OUT PROCEDURE, THE TERMINAL PIN OF THIS RIGHT VENTRICULAR (RV) LEAD SEPARATED FROM THE LEAD BODY. THIS LEAD WAS SURGICALLY ABANDONED AND WAS SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439630 BIOPORE IMPLANTABLE LEAD DTB GUIDANT ANGLETON/ST. PAUL 430-02

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR 294-03| K173| 438-05| 404-01| 430-02| 1290| 4470| 1280| 284-05