BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4831781 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05355
    Event Type
    Malfunction
    Date Received
    June 10, 2015
    Date of Event
    March 30, 2015
    Report Date
    March 30, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    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 PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD NOISE. IT WAS NOTED THAT THE RV LEAD WAS WITHIN NORMAL RANGE FOR IMPEDANCE AND THRESHOLD. FOLLOW UP WAS COMPLETED FOR TROUBLESHOOTING OR INTERVENTION AND NO FURTHER INFORMATION WAS OBTAINED. 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
    375816 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR 407645 LEAD, ADDR01 IPG