BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSYNC MAXIMO

    MDR report key: 2083043 · Received May 10, 2011

    Report

    Report Number
    6000144-2011-02069
    Event Type
    Death
    Date Received
    May 10, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    PMA / PMN Number
    P010031/S013
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    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. PER LEGAL ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT AND NO FURTHER INFORMATION IS AVAILABLE. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE.

    Description of Event or Problem · 1

    AN ALLEGATION FROM AN ATTORNEY INDICATED THE PATIENT DIED APPROXIMATELY 3 MONTHS POST IMPLANT OF THE IMPLANTABLE DEFIBRILATOR SYSTEM. IT WAS ALSO NOTED THE PATIENT SUFFERED EXTREME PHYSICAL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC MAXIMO IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. 7303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| O