BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SD 75/18

    MDR report key: 1964059 · Received January 11, 2011

    Report

    Report Number
    1028232-2011-00008
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    October 2, 2010
    Report Date
    January 4, 2011
    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

    THIS PATIENT EXPERIENCED A SYNCOPAL EPISODE. THE PATIENT WAS REFERRED FOR A LEAD REVISION, AND ON (B)(6) 2010, BOTH THIS RV LEAD AND THE COMPETITIVE LV LEAD WERE EXTRACTED AND REPLACED. NO ADDITIONAL INFORMATION IS AVAILABLE SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 75/18 ICD LEAD LWS BIOTRONIK SE & CO. KG, 350056

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization