BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 1072400 · Received July 10, 2008

    Report

    Report Number
    2649622-2008-03646
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    January 9, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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. 5092 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Required Intervention ASDR01 IMPLANTABLE PULSE GENERATOR