BEUDAMED
    FDA Adverse Event Death Summary report: N

    54 CM BIPOLAR LEAD

    MDR report key: 3597136 · Received January 24, 2014

    Report

    Report Number
    2183787-2014-00011
    Event Type
    Death
    Date Received
    January 24, 2014
    Date of Event
    December 2, 2013
    Report Date
    January 4, 2014
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DTB
    PMA / PMN Number
    P130012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PT DEATH. DEATH REPORT DATE WAS (B)(6) 2013. NO CAUSE OR ALLEGATION AGAINST ANY IMPLANTED PRODUCT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57120 54 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511212 W2435444

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| R