BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSYNC II MARQUIS

    MDR report key: 1041086 · Received May 12, 2008

    Report

    Report Number
    6000094-2008-00225
    Event Type
    Death
    Date Received
    May 12, 2008
    Date of Event
    May 17, 2005
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. OUR RECORDS INDICATE THE PATIENT EXPIRED MORE THAN ONE YEAR AGO. WE HAVE NO INFORMATION TO SUGGEST THE DEATH WAS DEVICE RELATED. EVALUATION SUMMARY BATTERY - BATTERY DEPLETION-NORMAL.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC II MARQUIS IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. 7289 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other