BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 340 VR-T

    MDR report key: 1902556 · Received November 12, 2010

    Report

    Report Number
    1028232-2010-02409
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    July 26, 2010
    Report Date
    October 22, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT COMPLAINED OF PAIN AROUND DEVICE WHEN MOVING. DEVICE WAS EXPLANTED ON (B)(6) 2010. THE FOLLOW PHYSICIAN'S OFFICE HAS NO COMPLAINTS AGAINST THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 340 VR-T ICD LWS BIOTRONIK SE & CO. KG 355271

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Hospitalization