BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z NOVUS LEAD

    MDR report key: 8806920 · Received July 19, 2019

    Report

    Report Number
    2649622-2019-12642
    Event Type
    Malfunction
    Date Received
    July 19, 2019
    Date of Event
    June 26, 2019
    Report Date
    July 19, 2019
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00681490135047
    PMA / PMN Number
    P850089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: SEDR01 IPG, IMPLANTED: (B)(6) 2010. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NOISE AND NON-PHYSIOLOGICAL INTERVALS WERE NOTED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601083 CAPSURE Z NOVUS LEAD ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5554-45 00681490135047

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR 5054-52 LEAD