BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIXNOVUS

    MDR report key: 2954633 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02316
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    December 20, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS OVERSENSING OBSERVED IN THE RIGHT ATRIAL LEAD AND FURTHER EVALUATION WAS PLANNED. THE LEAD 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
    58361 CAPSUREFIXNOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR KDR901 IMPLANTABLE PULSE GENERATOR