BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 340 DR-T

    MDR report key: 2844855 · Received November 2, 2012

    Report

    Report Number
    1028232-2012-02713
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    September 27, 2012
    Report Date
    October 24, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P000009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS ICD WAS REMOVED AND REPLACED DUE TO NOISE AND INAPPROPRIATE SHOCK. THE ICD LEAD WAS REMOVED AND REPLACED AT THE SAME TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 340 DR-T ICD MRM BIOTRONIK SE & CO. KG 355267

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization