BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3992255 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09974
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    November 1, 2013
    Report Date
    June 18, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. PRODUCTS: 4076 LEAD IMPLANTED: 2011 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WARNING TRIGGERED TEN MONTHS PRIOR, AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A LOSS OF CAPTURE WITH ISOMETRICS AND A POLARITY SWITCH. RECENT REVIEW OF THE RV LEAD MEASUREMENTS INDICATES NORMAL FUNCTION, HOWEVER, THE ATRIAL LEAD NOW EXHIBITS HIGH IMPEDANCES AND INHIBITION WAS NOTED WITH ISOMETRICS. THE LEADS 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
    469382 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR ADDR01 IPG