BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3160274 · Received June 10, 2013

    Report

    Report Number
    2649622-2013-07974
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 PRODUCTS: 6947 IMPLANTABLE TACHY LEAD (B)(6) 2008; 4194 LEFT VENTRICULAR (LV) LEAD (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY REMOTE TRANSMISSION THE ATRIAL LEAD REVEALED UNDER SENSING ON A STORED DIAGNOSTIC. IT WAS ALSO NOTED THE LEFT VENTRICULAR (LV) LEAD THRESHOLD HAD INCREASED GREATER THAN THE PROGRAMMED SAFETY MARGIN. THE DEVICE AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261354 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR D224TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR