BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYLOS DR-T

    MDR report key: 3200342 · Received July 1, 2013

    Report

    Report Number
    1028232-2013-01825
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    November 6, 2012
    Report Date
    June 13, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OUS MDR - AT THE END OF A ROUTINE FOLLOW-UP, THE PROGRAMMING HEADER WAS REMOVED. THIS RESULTED IN A PRESYNCOPE AND FALLING QRS COMPLEX IN THE ONGOING EKG. AFTER A REPEATED FOLLOW-UP, NO PECULIARITIES WERE NOTED. THIS WAS ALL OF THE INFORMATION PROVIDED TO US. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299770 CYLOS DR-T PACEMAKER DXY BIOTRONIK SE & CO. KG 349806

    Patients

    Seq Age Sex Outcome Treatment
    1 Other