BEUDAMED
    FDA Adverse Event Death Summary report: N

    54 CM BIPOLAR LEAD

    MDR report key: 3181312 · Received June 14, 2013

    Report

    Report Number
    2183787-2013-00055
    Event Type
    Death
    Date Received
    June 14, 2013
    Date of Event
    April 23, 2013
    Report Date
    June 14, 2013
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    K925099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY AND THE ENTIRE IMPLANTED SYSTEM WAS EXTRACTED DUE TO INFECTION. AT THE TIME OF THE EXPLANT PROCEDURE, THE PHYSICIAN ELECTED TO IMPLANT TWO EPICARDIAL LEADS. THERE WAS NO PRODUCT EXPERIENCE ISSUES AS THE EPICARDIAL LEADS WERE IMPLANTED IN THE EVENT, THE PT RECOVERED FROM THE INFECTION. SUBSEQUENTLY, INFORMATION WAS RECEIVED THAT THIS PT DIED SIX DAYS LATER. ACCORDING TO THE PHYSICIAN, THE PT HAD DEVELOPED A POCKET INFECTION WHICH NECESSITATED THE SYSTEM EXPLANT. THE CAUSE OF DEATH WAS ATTRIBUTED TO A TEAR OF THE SUPERIOR VENA CAVA (SVC).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271038 54 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511212 W1941836

    Patients

    Seq Age Sex Outcome Treatment
    1 Death