BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXIOS D

    MDR report key: 709737 · Received May 5, 2006

    Report

    Report Number
    1028232-2006-00055
    Event Type
    Other
    Date Received
    May 5, 2006
    Date of Event
    February 23, 2006
    Report Date
    May 4, 2006
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH SYNCOPAL EPISODES. THE PACEMAKER CHECK DURING THE FOLLOW-UP EXAMINATION HAD BEEN UNREMARKABLE. NO EXIT BLOCK COULD BE PROVOKED IN THE VENTRICLE. IN THE FURTHER COURSE OF THE HOSPITAL STAY, THE PATIENT WAS SYNCOPAL ONCE MORE DUE TO PACING LOSS. THE REVISION DID NOT FIND ANYTHING UNUSUAL. THE PHYSICIAN DECIDED TO EXCHANGE THE ENTIRE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXIOS D PACEMAKER DXY BIOTRONIK GMBH AND CO. 338843 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention