BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    35 CM BIPOLAR LEAD

    MDR report key: 2844426 · Received November 5, 2012

    Report

    Report Number
    2183787-2012-00086
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Report Date
    November 2, 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

    INFO WAS RECEIVED THAT THIS EPICARDIAL LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE DUE TO PACING THRESHOLDS GREATER THAN 7.5V AT 2.0 MS. THE LEAD WAS CAPPED AND SURGICALLY ABANDONED. 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 W1441487

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention