BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCERTO CRT-D DR

    MDR report key: 1039857 · Received May 9, 2008

    Report

    Report Number
    2647346-2008-00246
    Event Type
    Injury
    Date Received
    May 9, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ID IS INCORRECT AND IS NOT ASSOCIATED WITH THIS EVENT. THE CORRECT DEVICE ID HAS BEEN SUBMITTED UNDER ANOTHER FDA REPORT NUMBER; REFERENCE 2647346-2008-00491.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONCERTO CRT-D DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB DXY MEDTRONIC MED REL, INC. C154DWK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention 6947 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD