BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERA-I DR

    MDR report key: 1001937 · Received February 7, 2008

    Report

    Report Number
    2647346-2008-00070
    Event Type
    Injury
    Date Received
    February 7, 2008
    Date of Event
    January 17, 2008
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    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 THERA-I DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. 7960IU NA

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention 4965 IMPLANTABLE PACING LEAD