BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC MAXIMO

    MDR report key: 1013413 · Received March 10, 2008

    Report

    Report Number
    6000144-2008-00049
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    January 30, 2006
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention 4193 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD