BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3275653 · Received August 9, 2013

    Report

    Report Number
    2649622-2013-08326
    Event Type
    Malfunction
    Date Received
    August 9, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    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: 5554-53 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2000. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PERIODIC FOLLOW-UP, THERE WAS A LEAD WARNING FOR THE ATRIAL LEAD DUE TO LOW IMPEDANCE. THE ATRIAL LEAD WAS REPROGRAMMED FROM BIPOLAR TO UNIPOLAR. BECAUSE OF THIS, OVERSENSING OF MYOGENIC POTENTIALS WAS SEEN AND THE SENSITIVITY WAS ALSO REPROGRAMMED. IT WAS ALSO REPORTED THAT AN INCREASED VENTRICULAR LEAD THRESHOLD WAS SEEN. BOTH LEADS REMAIN IN USE UNTIL THE NEXT FOLLOW-UP. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377765 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5054-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR ADDRS1 IMPLANTABLE PACEMAKER