BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIXNOVUS

    MDR report key: 2955186 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-00779
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    November 16, 2012
    Report Date
    December 3, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    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 PRODUCT: 6947 IMPLANTABLE DEFIBRILLATION LEAD (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY REMOTE TRANSMISSION THAT THERE WAS SOME FAR-FIELD OVERSENSING ON THE ATRIAL LEAD. THE LEAD IS STILL 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
    58351 CAPSUREFIXNOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR D314DRM IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC