BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SMART SD 65/18

    MDR report key: 2232535 · Received August 19, 2011

    Report

    Report Number
    1028232-2011-01878
    Event Type
    Injury
    Date Received
    August 19, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 11, 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 SYSTEM WAS EXTRACTED DUE TO (B)(6) AND HAS NOT YET BEEN REPLACED.

    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 58 YR Hospitalization