BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERA-I SR

    MDR report key: 1072170 · Received July 10, 2008

    Report

    Report Number
    2647346-2008-00329
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    July 3, 2007
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERA-I SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. 8962 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Required Intervention 4068 IMPLANTABLE PACING LEAD