BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SMART SD 60/16

    MDR report key: 2101487 · Received May 17, 2011

    Report

    Report Number
    1028232-2011-01117
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 15, 2011
    Report Date
    May 9, 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 LEAD PERFORATED THE HEART AND WAS EXPLANTED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SMART SD 60/16 ICD LEAD LWS BIOTRONIK SE & CO. KG 359065

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization