BEUDAMED
    FDA Adverse Event Death Summary report: N

    54 CM BIPOLAR LEAD

    MDR report key: 2440840 · Received February 2, 2012

    Report

    Report Number
    2183787-2012-00010
    Event Type
    Death
    Date Received
    February 2, 2012
    Report Date
    February 1, 2012
    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

    EVALUATION OF DEVICE IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    (B)(6) RECEIVED THIS LEAD WITH INFORMATION THAT THE PATIENT HAD DIED OF CARDIAC ARREST. THE PATIENT HAD BEEN IN RENAL FAILURE FOR 2 YEARS AND HAD CARDIAC DISEASE FOR 20 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 54 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511212 W44293

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death