BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3861950 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07122
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 25, 2014
    Report Date
    March 25, 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
    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 AT THE TIME OF AN UNRELATED LEAD REVISION, THE RIGHT VENTRICULAR (RV) LEAD SHOWED HIGH IMPEDANCE. IT WAS ASSUMED THAT THIS WAS DUE TO THE LEAD REPOSITIONING DURING THE UNRELATED REVISION. IT WAS ALSO REPORTED THAT THERE WAS LOW PACING IMPEDANCE. THE PATIENT WENT ON VACATION AND HAD AN EPISODE OF PRE-SYNCOPE. THE PATIENT WENT TO THE HOSPITAL WHERE THEY NOTED A POLARITY SWITCH. REPROGRAMMING WAS DONE AND THE PATIENT WAS ADVISED TO SEE THE DOCTOR UPON RETURNING HOME. DURING THE FOLLOW-UP VISIT, THE LEAD IMPEDANCE WAS STILL HIGH. REPROGRAMMING WAS DONE AGAIN. CLOSE MONITORING WILL CONTINUE. ALL OTHER TESTS ARE WITHIN NORMAL RANGE. 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
    337080 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5054-58

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R ADDRL1 IMPLANTABLE PULSE GENERATOR (IPG)