BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/18

    MDR report key: 2132304 · Received June 13, 2011

    Report

    Report Number
    1028232-2011-01263
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 11, 2011
    Report Date
    June 1, 2011
    Manufacturer
    BIOTRONIK SE & CO., KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS REMOVED BECAUSE THE PT WAS INAPPROPRIATELY SHOCKED DUE TO LEAD FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/18 ICD LEAD LWS BIOTRONIK SE & CO., KG 350054

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization