BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SMART SD 65/18

    MDR report key: 2833130 · Received November 7, 2012

    Report

    Report Number
    1028232-2012-02778
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 26, 2012
    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

    THERE WAS A LEAD REVISION DONE ON THIS LEAD BECAUSE, IT HAD DISLODGED. THE LEAD REMAINS ACTIVELY IMPLANTED. THERE WERE NO ADVERSE EVENTS REPORTED FOR THE PT. SHOULD ADD'L INFO BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SMART SD 65/18 ICD LEAD LWS BIOTRONIK SE & CO KG 359067

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization