BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 1072634 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03463
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    August 29, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DXY
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    INVALID DATA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE Z NOVUS IMPLANTABLE PACING LEAD DXY MEDTRONIC PUERTO RICO, INC. 5054 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention KDR401 IMPLANTABLE PULSE GENERATOR| 5568 IMPLANTABLE PACING LEAD