BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3152149 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05535
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    March 2, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. PRODUCT: 5076 IMPLANTABLE PACING LEAD 2011 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY REMOTE TRANSMISSION THERE WAS ATRIAL LEAD UNDERSENSING. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS WERE PORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252899 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)