BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1050010 · Received May 8, 2008

    Report

    Report Number
    2649622-2008-02601
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 22, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    INVALID DATA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4092 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention 4592 IMPLANTABLE PACING LEAD| KDR901 IMPLANTABLE PULSE GENERATOR