BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KAPPA 700 DR

    MDR report key: 1072702 · Received July 10, 2008

    Report

    Report Number
    2647346-2008-00352
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    October 15, 2007
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    INVALID DATA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KAPPA 700 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. KDR701 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention 4592 IMPLANTABLE PACING LEAD| 4092 IMPLANTABLE PACING LEAD