BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3994221 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-10116
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    February 28, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 DURING A CLINIC VISIT THE ATRIAL AND VENTRICULAR LEADS EXHIBITED HIGH THRESHOLDS. NO ACTIONS WERE TAKEN, AND THE LEADS REMAIN IN USE. THE PATIENT WILL BE MONITORED CLOSELY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THIS PATIENT IS A PARTICIPANT IN THE (B)(6) STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467822 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5554-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR 383069 LEAD