BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOPAZ 3

    MDR report key: 1072118 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03850
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    March 17, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DXY
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOPAZ 3 IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC PUERTO RICO, INC. 540 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention ICQ09B IMPLANTABLE PACING LEAD