BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35 CM BIPOLAR LEAD

    MDR report key: 3043003 · Received March 7, 2013

    Report

    Report Number
    2183787-2013-00019
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    K925099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THIS LEFT VENTRICULAR (LV) LEAD EXHIBITED UNACCEPTABLE THRESHOLD MEASUREMENTS AND WAS FOUND TO HAVE BACKED OUT OF THE CARDIAC TISSUE. THE PUT UNDERWENT DOUBLE BYPASS SURGERY AND THE LEAD WAS CUT DURING THE PROCEDURE. THE LEAD WAS EXPLANTED AND SUCCESSFULLY REPLACED. NO ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98477 35 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511211 W2179842

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention