BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYLOS DR-T

    MDR report key: 934249 · Received October 25, 2007

    Report

    Report Number
    1028232-2007-00419
    Event Type
    Malfunction
    Date Received
    October 25, 2007
    Date of Event
    August 17, 2007
    Report Date
    September 27, 2007
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    DXY
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PER SOUND STUDY FORM, LOSS OF SENSING/NO P-WAVES MEASURED. STILL HAVE GOOD THRESHOLD. PACEMAKER WAS REPROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYLOS DR-T PACEMAKER DXY BIOTRONIK GMBH AND CO 349806

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention