BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONSULTA CRT-D

    MDR report key: 2040591 · Received April 6, 2011

    Report

    Report Number
    6000094-2011-00370
    Event Type
    Death
    Date Received
    April 6, 2011
    Date of Event
    February 27, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    REVIEW OF MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED 19 DAYS AFTER A DEVICE IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULTA CRT-D IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death