BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONCERTO II CRT-D

    MDR report key: 2042684 · Received April 6, 2011

    Report

    Report Number
    2647346-2011-00423
    Event Type
    Death
    Date Received
    April 6, 2011
    Date of Event
    March 8, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S125
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. 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 A PATIENT WHO HAD AN IMPLANTABLE CARDIAC DEFIBRILLATOR DIED. THERE WAS A REPORT THAT THERE WAS OVERSENSING THAT OCCURRED RESULTING IN A NON SUSTAINED TACHYCARDIA EPISODE. THE T-WAVE OVERSENSING RESOLVED AND THE PATIENT RETURNED TO PACING. THIS EPISODE OCCURRED TWELVE DAYS PRIOR TO THE DAY OF DEATH. ON THE DAY OF DEATH AN AGONAL RHYTHM WAS RECORDED. CAUSE OF DEATH HAD BEEN REQUESTED AND NOT RECEIVED.

    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