BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    54 CM BIPOLAR LEAD

    MDR report key: 2101912 · Received May 2, 2011

    Report

    Report Number
    2183787-2011-00032
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    K925099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW AND CONFIRMATION OF MFG RECORDS WAS PERFORMED. NO ANOMALIES WERE FOUND. CONCLUSION: IT CANNOT BE DETERMINED WHETHER THE EVENT WAS RELATED TO DEVICE PERFORMANCE, OR PT CONDITION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC REC'D INFO THAT THIS EPICARDIAL LEAD HAD BEEN USED FOR LEFT VENTRICULAR (LV) PACING AND WAS SURGICALLY ABANDONED DUE TO HIGH THRESHOLDS. THERE WERE NO ISSUES WITH NOISE, SENSING OR IMPEDANCE MEASUREMENTS ON THE LEAD. THIS LEAD WAS REPLACED WITH A DIFFERENT LV EPICARDIAL LEAD THAT HAD BEEN PREVIOUSLY IMPLANTED. NO ADVERSE PT EVENTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 54 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511212 W1645071

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention