BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART S 65

    MDR report key: 4110015 · Received September 23, 2014

    Report

    Report Number
    1028232-2014-003392
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 19, 2014
    Report Date
    September 15, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE ANALYSIS OF THE LEAD, IT WAS NOTED THAT THE INSULATION WAS DAMAGE IN THE AREA OF THE VALVE PLANE. THIS DAMAGE CAN WITH HIGH PROBABILITY BE REGARDED THE CAUSE FOR THE CLINICAL COMPLAINT. THE OBSERVED DAMAGE MANIFESTATION REQUIRES STRESS ON THE LEAD OVER A LONGER PERIOD OF TIME. THE POSITION AND CHARACTERISTICS OF THE FRAYING LEAD TO THE ASSUMPTION OF SIGNIFICANT MECHANICAL STRESS ON THE LEAD. X-RAY IMAGES OR DIAGNOSTIC IMAGES OF ANY OTHER KIND THAT 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 19 MONTHS, OVERSENSING WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE TO THIS INCIDENT. THE LEAD WAS RETURNED TO BIOTRONIK FOR ANALYSIS. NO WORSENING OF THE PATIENT'S STATE OF HEALTH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590026 LINOX SMART S 65 ICD LEAD NVY BIOTRONIK SE & CO. KG 369818

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization