BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35 CM BIPOLAR LEAD

    MDR report key: 3021090 · Received March 20, 2013

    Report

    Report Number
    2183787-2013-00020
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    K925099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS TAKEN OUT OF SERVICE DUE TO CAPTURE ANOMALY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116336 35 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511211 W1482320

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention