BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX TD 65/18

    MDR report key: 2800303 · Received October 9, 2012

    Report

    Report Number
    1028232-2012-02533
    Event Type
    Malfunction
    Date Received
    October 9, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 27, 2012
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF 64 MONTHS, OVERSENSING WAS REPORTED. NO DETERIORATION IN THE PT'S STATE OF HEALTH WAS REPORTED. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX TD 65/18 ICD LEAD LWS BIOTRONIK SE & CO. KG 351338

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization