BEUDAMED
    FDA Adverse Event Injury Summary report: N

    35 CM BIPOLAR LEAD

    MDR report key: 3961621 · Received June 16, 2014

    Report

    Report Number
    2183787-2014-00084
    Event Type
    Injury
    Date Received
    June 16, 2014
    Report Date
    July 2, 2014
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    P130012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    INFO WAS RECEIVED THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353324 35 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511212 W37032

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention