BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/18

    MDR report key: 1913507 · Received November 24, 2010

    Report

    Report Number
    1028232-2010-02611
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 15, 2010
    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 DEVICE WAS EXPLANTED BECAUSE, HOME MONITORING SHOWED AN INCREASE IN DAILY SHOCK IMPEDANCE. THE PT WAS BROUGHT IN AND THE DEVICE WAS INTERROGATED; THE PT WAS INDUCED AND DEVICE DID NOT DELIVER THERAPY.

    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 56 YR Hospitalization