BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35 CM BIPOLAR LEAD

    MDR report key: 3243114 · Received July 18, 2013

    Report

    Report Number
    2183787-2013-00056
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    July 1, 2013
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    P130012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A LEAD PROBLEM WAS REPORTED WHEN A PT PRESENTED IN THE OPERATING ROOM FOR RV LEAD REPLACEMENT. THE RV LEAD HAD LOW IMPEDANCE MEASUREMENTS IN THE 100 S. RV SENSING ALSO DECREASED DOWN TO 3 MV, AND THE RV OUTPUTS WERE INCREASED DUE TO ELEVATED THRESHOLDS UP TO 5 V AT 0.04 MS. THE PHYSICIAN WILL BE REPLACING THE LEAD WITH A PREVIOUSLY CAPPED LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335566 35 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511211 W2223500

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention