BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3152472 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06799
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. CONCOMITANT PRODUCTS: (B)(4) IMPLANTABLE PULSE GENERATOR 2005 (B)(6); 5054-52 IMPLANTABLE PACING LEAD 2005 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THEIR PHYSICIAN DUE TO PALPITATIONS. NOISE WAS CONFIRMED ON BOTH THE ATRIAL AND VENTRICULAR CHANNELS WHEN THE PATIENT RAISED AND LOWERED THEIR ARMS. IT WAS NOTED THAT FIVE MONTHS EARLIER, THERE WAS A LEAD WARNING FOR HIGH IMPEDANCE FOR THE RIGHT VENTRICULAR (RV) LEAD AND THERE WAS INCREASED IMPEDANCE FOR THE RIGHT ATRIAL (RA) LEAD. CONSEQUENTLY THE RV LEAD WAS EXPLANTED AND WAS REPLACED. THE PATIENT CONTINUES TO BE MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253070 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC INC. 5554-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR