BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 2810502 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15749
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    February 7, 2012
    Report Date
    December 12, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089/S38
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN IMPEDANCE INCREASE AND HIGH IMPEDANCE ON THE RIGHT ATRIAL LEAD. IT WAS LATER REPORTED THAT THE ATRIAL LEAD HAD SWITCHED TO UNIPOLAR DUE TO THE HIGH IMPEDANCE. IT WAS RECOMMENDED TO PROGRAM THE ATRIAL LEAD BACK TO BIPOLAR SINCE NOISE WAS NOTED IN UNIPOLAR POLARITY AND CHANGE UPPER LIMIT OF THE LEAD MONITOR. THE LEAD WILL CONTINUE TO BE MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN IMPEDANCE INCREASE AND HIGH IMPEDANCE ON THE RIGHT ATRIAL LEAD. THE PATIENT WILL BE BROUGHT IN TO TRY ISOMETRICS. 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
    1 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5554

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other 5054 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR