BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSYNC III

    MDR report key: 2063468 · Received April 19, 2011

    Report

    Report Number
    6000144-2011-02046
    Event Type
    Death
    Date Received
    April 19, 2011
    Date of Event
    May 5, 2006
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P010015/S005
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE(S) ASSOCIATED WITH THIS ADVERSE OUTCOME ARE ASSOCIATED WITH A PATIENT DEATH THAT OCCURRED APPROXIMATELY FIVE YEARS AGO. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT 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 WAS DECEASED AND DIED APPROXIMATELY SEVEN MONTHS AFTER BI-VENTRICULAR PACEMAKER SYSTEM UPGRADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC III IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. 8042 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death