BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SD 65/18

    MDR report key: 1882319 · Received October 22, 2010

    Report

    Report Number
    1028232-2010-02199
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    July 16, 2010
    Report Date
    September 22, 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
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS OF THE LEAD DETECTED THAT THE INSULATION WAS DAMAGED BY FRAYING. THIS DAMAGE CAN WITH HIGH PROBABILITY BE REGARDED THE CAUSE FOR THE CLINICAL COMPLAINT. THE OBSERVED DAMAGE MANIFESTATION REQUIRES AN EXCESSIVE MECHANICAL LOAD ON THE LEAD OVER A LONGER PERIOD OF TIME. THE POSITION AND CHARACTERISTICS OF THE FRAYING LEAD TO THE ASSUMPTION OF EXCESSIVE MECHANICAL LOAD ON THE LEAD IN THE AREA OF THE VALVULAR PLANE. X-RAY IMAGES OR DIAGNOSTIC IMAGES OF ANY OTHER KIND, WHICH COULD PROVIDE INFORMATION ON THE POSITIONAL RELATIONSHIPS OF THE IMPLANTED SYSTEM IN THE BODY, WERE NOT AVAILABLE FOR ANALYSIS. THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 22 MONTHS, INAPPROPRIATE SHOCK DELIVERIES WERE REPORTED AND THE LEAD WAS EXPLANTED. NO DETERIORATION OF THE PATIENT'S STATE OF HEALTH WAS REPORTED.

    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 UNK Hospitalization