BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC ICD

    MDR report key: 1013562 · Received March 10, 2008

    Report

    Report Number
    6000094-2008-00048
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    December 13, 2006
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NIK
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    INVALID DATA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYNC ICD IMPLANTABLE PACEMAKER/CARDIO/DEFIB NIK MEDTRONIC S.A. 7272 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other 4193 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| 4068 IMPLANTABLE PACING LEAD