BEUDAMED
    FDA Adverse Event Injury Summary report: N

    35CM BIPOLAR LEAD

    MDR report key: 2335006 · Received November 8, 2011

    Report

    Report Number
    2183787-2011-00078
    Event Type
    Injury
    Date Received
    November 8, 2011
    Report Date
    November 7, 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

    THE DEVICE WAS RETURNED TO GREATBATCH MEDICAL FOR EVALUATION. HOWEVER, EVALUATION IS NOT YET COMPLETE ON THE DEVICE. ONCE THE RESULTS OF THIS EVALUATION ARE COMPLETE THIS MDR WILL BE UPDATED.

    Description of Event or Problem · 1

    THIS LEAD WAS REMOVED DUE TO PATIENT INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 35CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511211 W1483141

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention