BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO II CRT-D

    MDR report key: 2077006 · Received May 4, 2011

    Report

    Report Number
    2647346-2011-00643
    Event Type
    Death
    Date Received
    May 4, 2011
    Date of Event
    March 10, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S125
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS INVOLVED IN A SETTLEMENT INVOLVING THE SPRINT FIDELIS LEAD MODEL CAPTURED IN E912827. PER LEGAL, ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT AND NO FURTHER INFORMATION IS AVAILABLE. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A URINARY TRACT INFECTION/ISSUE AND WAS ADMITTED A FEW DAYS LATER. THEN THE PATIENT WAS ADMITTED TO THE CARE OF HOSPICE WITH A SLIGHT FEVER AND NOT VERY RESPONSIVE. THE PATIENT LATER DIED. INFORMATION IDENTIFIED IN THE MANUFACTURE DATA BASE REVEALED THE PATIENT DIED SEVEN DAYS POST IMPLANT OF THE CRT-D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO II CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D274TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death