BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3992818 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09660
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THERE WAS A LARGE AMOUNT OF MODE-SWITCHES OCCURRING FROM NOISE, HIGH IMPEDANCE, AND HIGH THRESHOLD ASSOCIATED WITH THE LEAD. THE PATIENT COMPLAINED OF DIZZY SPELLS AND PALPITATIONS. THE LEAD PROGRAMMING WAS CHANGED, AND THE PHYSICIAN IS MONITORING THE LEAD FOR POTENTIAL REPLACEMENT. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471750 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5554

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R