BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SMART SD 60/16

    MDR report key: 2922533 · Received January 15, 2013

    Report

    Report Number
    1028232-2013-00008
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 28, 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

    THIS SYSTEM WAS REMOVED DUE TO A (B)(6) INFECTION. THE HOSP RETAINED THE DEVICES. SHOULD ADD'L INFO BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22605 LINOX SMART SD 60/16 ICD LEAD LWS BIOTRONIK SE & CO KG 359065

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization