BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 2791690 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14553
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE INCREASING AND HIGH LEAD IMPEDANCE VALUES IN THE RIGHT ATRIAL LEAD. INCREASING IMPEDANCE, HIGH IMPEDANCE VALUES AND INCREASING THRESHOLDS WERE ALSO REPORTED IN THE RIGHT VENTRICULAR PACING LEAD. THE LEADS CONTINUE TO BE MONITORED AND REMAIN IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE SP NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5092

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other (B)(4) IMPLANTABLE PULSE GENERATOR