BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3992873 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09608
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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: PRODUCT ID D354TRG, SERIAL# (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ALERT FOR ATRIAL IMPEDANCE THAT WAS TRIGGERED DUE TO A SINGLE OUT OF RANGE LEAD IMPEDANCE MEASUREMENT FROM HIGH IMPEDANCES. ADDITIONALLY, IT WAS REPORTED THAT THE DEVICE IS CURRENTLY PROGRAMMED VVIR (VENTRICLE,VENTRICLE, INHIBITED, RATE MODULATION) AS THE PATIENT HAS CHRONIC AF (ATRIAL FIBRILLATION) AND THEREFORE THE ATRIAL LEAD HAS NO FUNCTION. THE ALARM FOR THE ATRIAL LEAD WAS SET TO OFF AND THE LEAD REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THISEVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469495 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R D354TRG ICD