BEUDAMED
    FDA Adverse Event Death Summary report: N

    35 CM BIPOLAR LEAD

    MDR report key: 2949847 · Received February 6, 2013

    Report

    Report Number
    2183787-2013-00011
    Event Type
    Death
    Date Received
    February 6, 2013
    Date of Event
    December 22, 2012
    Report Date
    February 6, 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

    INFORMATION WAS RECEIVED THAT THE PATIENT WAS PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LAB FOR PLACEMENT OF AN EPICARDIAL LEFT VENTRICULAR (LV) LEAD. THE PATIENT'S PRIOR TRANSVENOUS LV LEAD HISTORY WAS SIGNIFICANT FOR DIAPHRAGMATIC STIMULATION. TWO DAYS FOLLOWING THE LV REVISION PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND DIED. THERE WERE NO ALLEGATIONS OR COMPLAINTS AGAINST THE CHRONIC DEVICE OR RECENTLY IMPLANTED EPICARDIAL LV LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51196 35 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511211 W2220462

    Patients

    Seq Age Sex Outcome Treatment
    1 Death