BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEXOS DR-T

    MDR report key: 1902865 · Received November 12, 2010

    Report

    Report Number
    1028232-2010-02317
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P000009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE ICD LEAD SHOWS NOISE ON THE ELECTROGRAM CAUSING VF DETECTIONS AND 20 SHOCKS. AN INSULATION BREAK ON THE RIGHT VENTRICULAR ICD LEAD IS SUSPECTED. AFTER 20 SHOCKS WERE DELIVERED THE DEVICE WAS REPORTING EOS. AFTER THE SHOCKS, NO PACING IS SEEN. THE DEVICE AND LEAD WILL BE EXPLANTED. ON (B)(6)2010 - THIS DEVICE WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEXOS DR-T ICD MRM BIOTRONIK SE & CO. KG 347001

    Patients

    Seq Age Sex Outcome Treatment
    1 100 YR Hospitalization