BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEXOS VR-T

    MDR report key: 1841557 · Received September 17, 2010

    Report

    Report Number
    1028232-2010-01894
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    April 16, 2010
    Report Date
    August 17, 2010
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR - UPON RECEIPT, THE DEVICE WAS INTERROGATED, REVEALING THE BATTERY STATUS EOS. THE DEVICE WAS IMPLANTED FOR 26 MONTHS AND 15 CHARGING CYCLES WERE RECORDED TO THE DEVICE MEMORY. THE EOS STATUS WAS REMOVED WITH A TECHNICAL PROGRAMMER AND THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE FLAWLESS IN AMPLITUDE AND FREQUENCY. A FIBRILLATION SIGNAL WAS APPLIED AND THE DEVICE DETECTED THE FIBRILLATION SIGNAL AS SPECIFIED AND STARTED THE CHARGING OF A DEFIBRILLATION SHOCK. HOWEVER, THE CHARGING WAS ABORTED, INDICATING A DEPLETED BATTERY. THE ICD WAS OPENED AND THE INNER ASSEMBLY WAS INSPECTED, REVEALING NO ANOMALIES. AN INCREASED CURRENT CONSUMPTION WAS IDENTIFIED, WHICH LED TO THE OBSERVED EARLY ERI DETECTION. FURTHER ANALYSIS REVEALED THAT THE INCREASED CURRENT CONSUMPTION RESULTED FROM A DAMAGED TRANSISTOR. THE DEVICE HISTORY DATA WAS INSPECTED AND REVEALED, THAT THERE WAS NO INDICATION OF A DEVICE MALFUNCTION DURING THE MANUFACTURING. PARTICULARLY, THE FINAL ACCEPTANCE TEST PROVED THE DEVICE TO BE FULLY FUNCTIONAL AT THAT TIME. THEREFORE, IT CANNOT BE EXCLUDED THAT THE OBSERVED DAMAGE RESULTED FROM EXTERNAL INFLUENCES AFTER THE DEVICE HAD LEFT BIOTRONIK. IN SUMMARY, THE CLINICAL OBSERVATION RESULTED FROM AN INCREASED CURRENT CONSUMPTION WHICH WAS CAUSED DUE TO A DAMAGED TRANSISTOR. THIS REPRESENTS A RANDOM COMPONENT FAILURE WITH NO SYSTEMATIC ROOT CAUSE.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF 26 MONTHS, THIS DEVICE WAS REMOVED DUE TO ERI. NO ADVERSE PT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization