BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4830831 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05819
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    March 18, 2015
    Report Date
    March 18, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS ATTEMPTED BUT NOT USED DUE TO HIGH IMPEDANCES AFTER SEVERAL REPOSITIONINGS. A SECOND RV LEAD WAS ATTEMPTED AND AGAIN HIGH IMPEDANCES WERE NOTED AS WELL AS HIGH THRESHOLDS. THE SECOND RV LEAD WAS REPOSITIONED IN A COMPLETELY DIFFERENT PLACE IN THE HEART WITH ACCEPTABLE READINGS. THE SECOND RV 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
    374882 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR