BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEXOS VR-T

    MDR report key: 967635 · Received December 19, 2007

    Report

    Report Number
    1028232-2007-00474
    Event Type
    Death
    Date Received
    December 19, 2007
    Date of Event
    May 31, 2007
    Report Date
    November 20, 2007
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P000009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR. THE DEVICE FIRST UNDERWENT A STATUS INTERROGATION. IT SHOWED THAT THE ICD COULD NOT BE INTERROGATED. THE ICD WAS THEN OPENED. THE BATTERY PROVED TO BE COMPLETELY DISCHARGED. DUE TO THE DISCHARGED STATE OF THE BATTERY, A TELEMETRIC CONNECTION AND THERAPY INTERROGATION WERE NOT POSSIBLE. THE BATTERY WAS SEPARATED AND THE ELECTRONIC MODULE WAS CONNECTED TO AN EXTERNAL POWER SUPPLY. AN INCREASED POWER UPTAKE WAS MEASURED. DAMAGE TO THE FINAL SHOCK STAGE WAS DISCOVERED. THE DAMAGE TO THE FINAL SHOCK STAGE RESULTED IN THE INCREASED POWER UPTAKE, WHICH LED TO THE DEPLETION OF THE BATTERY. THE ANALYSIS OF THE FINAL SHOCK STAGE SHOWED THAT THE DAMAGE HAD BEEN THE RESULT OF A SHOCK DELIVERY INTO A LOW-OHMIC SHOCK PATH. SINCE THE SHOCK CONDUCTORS OF THE ICD WERE INTACT, THE ICD WAS NOT THE CAUSE OF THE LOW-OHMIC SHOCK PATH. IN SUMMARY, THE CLINICAL OBSERVATION WAS THE RESULT OF A DAMAGED FINAL SHOCK STAGE, CAUSED BY A SHOCK DELIVERY INTO A LOW-OHMIC SHOCK PATH. THERE WAS, HOWEVER, NO MATERIAL DEFECT OR MANUFACTURING ERROR. RATHER, THE ANALYSIS POINTS TOWARD POSSIBLE LEAD DAMAGE.

    Description of Event or Problem · 1

    OUS MDR. PATIENT WAS FOUND DEAD ON THE WARD IN THE MORNING OF 2007. THE ICD COULD NOT BE INTERROGATED.

    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 YR Death