BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    54 CM BIPOLAR LEAD

    MDR report key: 3043020 · Received March 7, 2013

    Report

    Report Number
    2183787-2013-00018
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    March 4, 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

    INFO WAS RECEIVED THAT THIS LEFT VENTRICULAR (LV) LEAD WAS NOT WORKING. THE PHYSICIAN REQUESTED SPECIFICATIONS DUE TO POSSIBLE REPLACEMENT OF THE LV LEAD SYSTEM. FURTHER INFO WAS PROVIDED THAT THE PT UNDERWENT A REVISION PROCEDURE AS THE LEAD WAS NON-FUNCTIONAL. IT WAS OBSERVED THAT THE "LEAD WAS FOUND CUT IN THE POCKET." THE LEAD WAS SURGICALLY CAPPED AND ABANDONED. NO ADVERSE PT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98514 54 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511212 W1892051

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention