BEUDAMED
    FDA Adverse Event Death Summary report: N

    VICTORY XL DR

    MDR report key: 6169141 · Received December 13, 2016

    Report

    Report Number
    2017865-2016-07589
    Event Type
    Death
    Date Received
    December 13, 2016
    Date of Event
    November 21, 2016
    Report Date
    November 21, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LWP
    PMA / PMN Number
    P880086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PREMATURE BATTERY DEPLETION WAS SUSPECTED. EXPLANT OF THE DEVICE IS ANTICIPATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO REASONS UNRELATED TO THE REPORTED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821869 VICTORY XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC. 5816 2955713

    Patients

    Seq Age Sex Outcome Treatment
    1 Other