BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZEPHYR

    MDR report key: 6124263 · Received November 21, 2016

    Report

    Report Number
    MW5066259
    Event Type
    Death
    Date Received
    November 21, 2016
    Date of Event
    March 19, 2016
    Report Date
    November 21, 2016
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT EXPIRED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768388 ZEPHYR PACEMAKER LWP ST. JUDE MEDICAL 5826

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death A LEAD (MODEL 16887, SN# (B)(4))| V-LEAD (MODEL 1368, SN #(B)(4))