BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE FIX NOVUS

    MDR report key: 3160325 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-07953
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    March 19, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED ¿ABNORMAL¿ PACING IMPEDANCE, ALTHOUGH THERE WAS NO KNOWN CLINICAL PERFORMANCE ISSUE. THE LEAD REMAINS IN USE. THE PATIENT WAS A PARTICIPANT IN THE SYSTEM LONGEVITY STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260989 CAPSURE FIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076

    Patients

    Seq Age Sex Outcome Treatment
    1