BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMOS VR-T

    MDR report key: 1873434 · Received October 15, 2010

    Report

    Report Number
    1028232-2010-02083
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 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
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS FOUND IN SAFE MODE UPON INTERROGATION. REP WAS UNABLE TO MAINTAIN TELEMETRY WITH DEVICE DURING INTERROGATION. NO STATISTICS OR HOLTERS WERE AVAILABLE. EXPLANT WAS RECOMMENDED. HOSPITAL IS RETAINING THE DEVICE. IF THIS STATUS SHOULD CHANGE, THIS REPORT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMOS VR-T ICD LWS BIOTRONIK SE & CO. KG 353219

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization