BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3153053 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05792
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    March 18, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. CONCOMITANT PRODUCTS: D154AWG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), IMPLANTED: (B)(6) 2008; 694758 IMPLANTABLE TACHY LEAD, IMPLANTED: (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BATTERY DID NOT REACH THE EXPECTED LONGEVITY. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THERE WAS ELEVATED SENSING INTEGRITY COUNT (SIC) ON THE RIGHT VENTRICULAR (RV) LEAD. THERE WAS ALSO NOISE ON BOTH THE RV AND ATRIAL LEAD. ISOMETRIC EXERCISES AND POCKET MANIPULATION WERE DONE AND THE NOISE COULD NOT BE REPRODUCED. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254847 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR