BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3405160 · Received October 10, 2013

    Report

    Report Number
    2649622-2013-13386
    Event Type
    Malfunction
    Date Received
    October 10, 2013
    Report Date
    August 21, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    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. CONCOMITANT MEDICAL PRODUCTS: ADDR01 IMPLANTABLE PACING LEAD, (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD A WARNING FOR LOW IMPEDANCE PACES. THE CLINIC CHECK OF THE RA LEAD HAD IMPEDANCE OF 410 OHMS UNIPOLAR AND 475 OHMS BIPOLAR. WITH ISOMETRIC TESTING THE RA LEAD HAD NO CHANGES IN IMPEDANCES MEASUREMENTS. IT WAS NOTED THE RA LEAD HAD NO OVERSENSING AND THRESHOLDS WERE STABLE. THE RA LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519447 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR 507658 IMPLANTABLE PACING LEAD