BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEXOS VR

    MDR report key: 3193461 · Received June 27, 2013

    Report

    Report Number
    1028232-2013-01802
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 7, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE FIRST UNDERWENT A STATUS INTERROGATION, DURING WHICH THE DEVICE STATUS EOS WAS DISPLAYED; 183 CHARGE PROCESSES HAD BEEN DOCUMENTED. THE MEMORY CONTENT OF THE ICD WAS CHECKED; INTERFERENCE IN THE VENTRICULAR CHANNEL WAS VISIBLE ON THE AVAILABLE IEGMS. BETWEEN (B)(6) 2013, THESE INTERFERENCE SIGNALS LED TO MORE THAN 156, PARTIALLY TERMINATED, CHARGE PROCESSES. THE SIGNAL SENSING OF THE ICD WAS THEN CHECKED AND PROVED TO BE FREE OF NOISE. THE ICD SENSED SUPPLIED SIGNALS FREE OF INTERFERENCE. DURING THE ANALYSIS, THE ICD¿S CAPABILITY TO PROVIDE THERAPY WAS CHECKED. THE ANTIBRADYCARDIC OUTPUT SIGNAL WAS NORMAL AND MATCHED THE PROGRAMMED VALUES IN EOS MODE. THE EOS MODE WAS RESET WITH A TECHNICAL PROGRAMMER. A FIBRILLATION SIGNAL WAS SUPPLIED, AND THE DEVICE DETECTED THE FIBRILLATION SIGNAL AS EXPECTED. FOLLOWING THE DETECTION, A CHARGE PROCESS TOOK PLACE, WHICH WAS ABORTED, WHICH WAS, HOWEVER, DUE TO THE ALREADY SEVERELY DEPLETED BATTERY. THE ICD HAD BEEN IMPLANTED FOR 54 MONTHS, 183 CHARGE PROCESSES HAD BEEN DOCUMENTED. THE CHARGE DRAWN FROM THE BATTERY WAS CHECKED. DUE TO THE HIGH NUMBER OF CHARGE PROCESSES, THE BATTERY DEPLETION WAS AS EXPECTED. IN SUMMARY, THE ANALYSIS DID NOT PROVIDE ANY INDICATIONS OF A DEVICE MALFUNCTION, AND THE SIGNAL SENSING OF THE ICD IN PARTICULAR WAS NORMAL. THE BATTERY STATUS EOS RESULTED FROM THE SEVERE LOAD ON THE BATTERY CAUSED BY THE MULTITUDE OF SUBSEQUENT CHARGE PROCESSES, WHICH WERE TRIGGERED BY OVERSENSING. THERE WAS NO MATERIAL DEFECT OR MANUFACTURING ERROR.

    Description of Event or Problem · 1

    OUS MDR - IT WAS REPORTED THAT IN THE COURSE OF 2 WEEKS, THIS DEVICE WENT FROM AN EXPECTED ERI TO EOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294032 LEXOS VR ICD LWS BIOTRONIK SE & CO. KG 346998

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization