BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 636988 · Received September 9, 2005

    Report

    Report Number
    2649622-2005-00673
    Event Type
    Injury
    Date Received
    September 9, 2005
    Date of Event
    June 3, 2005
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DXY
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    LOSS OF V CAPTURE; PATIENT SYMPTOMATIC.

    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 71 YR Other