BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3993421 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09288
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    July 25, 2013
    Report Date
    May 23, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT PRODUCTS: 6947M LEAD IMPLANTED (B)(6) 2013; 4298 LEAD IMPLANTED (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AFTER IMPLANT, HIGH THRESHOLDS, UNDERSENSING, AND IMPEDANCE CHANGES WERE DETECTED ON THE RIGHT VENTRICULAR (RV) LEAD DUE TO DISLODGEMENT. THE ATRIAL LEAD ALSO RECORDED HIGH THRESHOLDS AND IMPEDANCE VALUE CHANGES. A LEAD REVISION WAS DONE TO REPOSITION THE RV AND ATRIAL LEADS. THE LEADS REMAIN IN USE. THIS PATIENT IS A PARTICIPANT IN A (B)(6) CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469314 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R DTBA2QQ CRTD