BEUDAMED
    FDA Adverse Event Death Summary report: N

    35 CM BIPOLAR LEAD

    MDR report key: 3812347 · Received May 6, 2014

    Report

    Report Number
    2183787-2014-00049
    Event Type
    Death
    Date Received
    May 6, 2014
    Date of Event
    October 2, 2013
    Report Date
    April 25, 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

    A DEVICE REGISTRATION FORM WAS RECEIVED STATING THAT THIS LEAD WAS IMPLANTED (B)(6) 2013. FURTHER INFO WAS PROVIDED THAT THIS PATIENT DIED (B)(6) 2013. CAUSE OF DEATH WAS LISTED AS "THE PATIENT HAD A STROKE, GOT A BREATHING TUBE, GOT AN INFECTION BECAUSE SHE COULD NOT EAT, AND THE INFECTION WENT TO HER HEART." NO ALLEGATION AGAINST ANY IMPLANTED PRODUCT WAS PROVIDED. THIS IS THE SAME EVENT AS MDR 2183787-2014-00048.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271930 35 CM BIPOLAR LEAD BIPOLAR LEAD DTB GREATBATCH MEDICAL 511211 W2361420

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death