BEUDAMED
    FDA Adverse Event Injury Summary report: N

    54 CM BIPOLAR LEAD

    MDR report key: 2950031 · Received February 6, 2013

    Report

    Report Number
    2183787-2013-00010
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    February 6, 2013
    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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE LEAD WAS PLACED OUT OF SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51109 54 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511212 M21940

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention