BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3152468 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06796
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 26, 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: D224TRK IMPLANTABLE CARDIOVERTER RESYNCHRONIZATION THERAPY-DEFIBRILLATOR, (B)(6) 2013; 694765 IMPLANTABLE TACHY LEAD, (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NOISE ON THE ATRIAL AND SVC (SUPERIOR VENA CAVA) COIL CHANNELS. THE PHYSICIAN BELIEVED THAT THE NOISE WAS MUSCLE POTENTIAL PRESENT IN THE SVC TO CAN VECTOR. IT WAS ALSO REPORTED THAT THE LV (LEFT VENTRICULAR) LEAD MOVED AND CAPTURE COULD NOT BE OBTAINED. THE LV LEAD WAS EXPLANTED AND REPLACED, AND THE RV (RIGHT VENTRICULAR) AND ATRIAL 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
    252826 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR 419688 IMPLANTABLE PACING LEAD