BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 2955406 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01396
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE PATIENT HAD A MAGNETIC RESONANCE IMAGING SCAN DONE OF THEIR BRAIN, THE DEVICE WAS FOUND TO HAVE HAD AN ELECTRICAL RESET. ALSO THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE HAD INCREASED BY APPROXIMATELY 54 OHMS. IT WAS NOTED THE THRESHOLDS WERE UNCHANGED AFTER THE SCAN. THE RESET WAS CLEARED AND THE DEVICE AND RV LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEENREPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59803 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5054-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR KDR901 IMPLANTABLE PULSE GENERATOR