BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 1072265 · Received July 10, 2008

    Report

    Report Number
    6000144-2008-00180
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    May 8, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NIK
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    INVALID DATA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC SENTRY IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC MED REL, INC. 7299 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention LEAD/PAC IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD