BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SD 65/16

    MDR report key: 2213009 · Received August 9, 2011

    Report

    Report Number
    1028232-2011-01771
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 19, 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 WAS CAPPED DUE TO POSSIBLE CRUSH. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/16 ICD LEAD LWS BIOTRONIK SE & CO. KG 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization