BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEXOS VR-T

    MDR report key: 1062197 · Received June 13, 2008

    Report

    Report Number
    1028232-2008-00656
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Report Date
    May 21, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ICD FIRST UNDERWENT A STATUS INTERROGATION, WHICH SHOWED THE DEVICE STATE AS ERI. THE ICD HAD BEEN IMPLANTED FOR 50 MONTHS, AND 208 CHARGE PROCESSES WERE DOCUMENTED. THE ICD'S ABILITY TO DELIVERY THERAPY WAS CHECKED. THE ANTIBRADYCARDIC OUTPUT SIGNAL WAS NORMAL AND MATCHED THE PROGRAMMED VALUES. A FIBRILLATION SIGNAL WAS FED IN AND THE DEVICE REACTED ACCORDING TO SPEC WITH A DEFIBRILLATION SHOCK. THE SPECIFIED ENERGY LEVEL WAS REACHED. THE CHARGE TIME WAS NORMAL. THE MEMORY CONTENT OF THE ICD WAS EXAMINED AND CONTAINED THE EXPECTED DATA. THE ANALYSIS OF THE IEGMS SHOWED INTERFERENCE IN THE VENTRICULAR CHANNEL. THE SIGNAL PERCEPTION OF THE ICD WAS TESTED AND PROVED TO BE FREE OF NOISE. THE ICD SENSED PROVIDED SIGNALS FREE OF INTERFERENCE. THE CHARGE DRAWN FROM THE BATTERY WAS TESTED. THE BATTERY DEPLETION PROVED TO BE AS EXPECTED. THE ANALYSIS DID NOT INDICATE A MATERIAL DEFECT OR MFG ERROR.

    Description of Event or Problem · 1

    OUS MDR. A SUDDEN INCREASE IN THE LEAD IMPEDANCE TO ABOUT 3 KOHM WITH SUSPICION OF LEAD FRACTURE WAS REPORTED AFTER AN IMPLANTATION TIME OF ABOUT 6 WEEKS. THE LEADS AND THE ICD WERE EXPLANTED. ALSO REMOVED: SELOX SR 60, MDR 1028232-2008-00657. KENTROX RV-S 65, MDR 1028232-2008-00655.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEXOS VR-T ICD LWS BIOTRONIK GMBH AND CO. 346999

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization