BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONSULTA

    MDR report key: 1994143 · Received February 16, 2011

    Report

    Report Number
    2647346-2011-00191
    Event Type
    Death
    Date Received
    February 16, 2011
    Date of Event
    January 5, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) WAS ELECTRICALLY ABANDONED DUE TO THE PATIENT HAVING ATRIAL FIBRILLATION ON (B)(6) 2010. THIS WOULD HAVE BEEN ONE MONTH PRIOR TO THE PATIENT'S DEATH. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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

    INFORMATION IDENTIFIED IN THE MANUFACTURER'S DATABASE NOTED THE PATIENT DIED LESS THAN A ONE MONTH POST IMPLANT OF THEIR BI-VENTRICULAR DEFIBRILLATOR. CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSULTA IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. D224TRK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death