BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    54 CM BIPOLAR LEAD

    MDR report key: 2012254 · Received February 2, 2011

    Report

    Report Number
    2183787-2011-00010
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Report Date
    February 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 MANUFACTURING 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 RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD WAS EXPLANTED DUE TO HIGH THRESHOLD MEASUREMENTS. THE PT REPORTED FEELING SOME MILD DIZZINESS PRIOR TO THE REPLACEMENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 54 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511212 W53580

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention