BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    54 CM BIPOLAR LEAD

    MDR report key: 3181831 · Received June 14, 2013

    Report

    Report Number
    2183787-2013-00053
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    June 14, 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

    LEAD WAS CAPPED DUE TO HIGH THRESHOLDS OCCURRED DURING A PROCEDURE TO REPLACE AN ICD FOR BATTERY REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272110 54 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511212 W57063

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention