BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SMART SD 60/16

    MDR report key: 2933079 · Received January 23, 2013

    Report

    Report Number
    1028232-2013-00093
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 10, 2013
    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 WAS EXPLANTED DUE TO DISLODGEMENT. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED. THE HOSPITAL RETAINED THE DEVICE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILL WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33621 LINOX SMART SD 60/16 ICD LEAD LWS BIOTRONIK SE & CO. KG 359065

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization