BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEXOS A+/T

    MDR report key: 1052009 · Received May 21, 2008

    Report

    Report Number
    1028232-2008-00522
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    December 8, 2007
    Report Date
    April 22, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P000009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR. THE ICD UNDERWENT A STATUS INTERROGATION, WHICH SHOWED THE DEVICE STATUS BOL AFTER AN IMPLANTATION TIME OF 9 MONTHS. THE SHOCK TABLE DOCUMENTS 51 CHARGE PROCESSES, MOST OF THEM ABORTED. THE MEMORY CONTENT OF THE ICD WAS CHECKED. THE RECORDED IEGMS SHOWED INTERFERENCE SIMULTANEOUSLY IN BOTH THE ATRIAL AND IN THE VENTRICULAR CHANNEL. IN CONSEQUENCE, THE SIGNAL SENSING OF THE ICD WAS CHECKED AND PROVED TO BE FREE OF NOISE. THE ICD SENSED APPLIED SIGNALS FREE FROM INTERFERENCE NEXT, THE ICD'S CAPABILITY TO PROVIDE THERAPIES WAS TESTED. THE ANTIBRADYCARDIC OUTPUT SIGNAL WAS NORMAL AND MATCHED THE PROGRAMMED VALUES. A FIBRILLATION SIGNAL WAS APPLIED AND THE DEVICE REACTED ACCORDING TO SPECIFICATION WITH A 30-JOULE DEFIBRILLATION SHOCK. THE SPECIFIED ENERGY LEVEL WAS REACHED. THE CHARGE TIME WAS NORMAL WITH 9.5 S. THE ANALYSIS DID NOT PROVIDE ANY INDICATIONS OF A MATERIAL DEFECT OR MANUFACTURING ERROR. THE ICD PROVED TO THE FULLY FUNCTIONAL. IN SUMMARY, THE ANALYSIS OF THE ICD DID NOT INDICATE ANY DEVICE DEFECT.

    Description of Event or Problem · 1

    OUS MDR. INAPPROPRIATE VF EPISODES WERE REPORTED AFTER AN IMPLANTATION TIME OF ABOUT 9 MONTHS. ALSO REMOVED WAS A KENTROX A+ 75/15 STEROID, MDR 1028232-2008-00521.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEXOS A+/T LWS BIOTRONIK GMBH AND CO. 347003

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization