BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/18

    MDR report key: 2233130 · Received July 22, 2011

    Report

    Report Number
    1028232-2011-01653
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NOISE WAS REPORTED ON THE LEAD CAUSING INAPPROPRIATE DETECTION AND SHOCK THERAPY. THE SOURCE OF THE NOISE IS UNK. ALL AVAILABLE INFO SUGGESTS THAT THIS LEAD REMAINS IMPLANTED. THIS IS ALL THE INFO AVAILABLE AT THIS TIME. SHOULD ADD'L INFO BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    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 68 YR Other