BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIXNOVUS

    MDR report key: 2965078 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01996
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    October 28, 2012
    Report Date
    December 10, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD (B)(6) 2003. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ATRIAL LEAD WARNING FOR NUMEROUS HIGH IMPEDANCE PACES. THERE WAS ALSO SOME NOISE AND OVERSENSING SEEN. 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
    69281 CAPSUREFIXNOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR KDR901 IMPLANTABLE PULSE GENERATOR