BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 7255381 · Received February 8, 2018

    Report

    Report Number
    2649622-2018-01148
    Event Type
    Injury
    Date Received
    February 8, 2018
    Date of Event
    November 14, 2017
    Report Date
    February 8, 2018
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00885074200682
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD SHOWED HIGH THRESHOLDS AND NO P-WAVES WERE SENSED. 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
    99210 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652 00885074200682

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention