BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35 CM BIPOLAR LEAD

    MDR report key: 2802544 · Received October 19, 2012

    Report

    Report Number
    2183787-2012-00085
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Report Date
    October 18, 2012
    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) EPICARDIAL LEAD WAS NO LONGER CAPTURING. THIS LEAD WAS REPLACED WITH THE SECOND LV LEAD ALREADY IMPLANTED. NO ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 35 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511211 W1884398

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention