BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART SD 65/16

    MDR report key: 3211817 · Received July 8, 2013

    Report

    Report Number
    1028232-2013-01855
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 25, 2013
    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, DAMAGE TO THE INSULATION AT APPROXIMATELY 18 CM DISTAL OF THE IS-1 CONNECTOR PIN, AS WELL AS DAMAGE TO THE COATING OF THE ROPE CONDUCTOR TO THE RING ELECTRODE IN THIS AREA WAS NOTED. THIS ERROR MANIFESTATION CAN WITH HIGH PROBABILITY BE REGARDED AS THE CAUSE OF THE CLINICAL COMPLAINT. THIS DAMAGE MANIFESTATION INDICATES SIGNIFICANT MECHANICAL STRESS DURING THE OPERATING TIME. THE POSITION AND CHARACTERISTICS OF THE EXTERNAL FRAYING ARE CHARACTERISTIC FOR A SIMULTANEOUS OCCURRENCE OF STRONG PRESSURE OF THE LEAD ONTO THE ICD HOUSING AND FRICTION OF THE LEAD AT THE ICD HOUSING. THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 20 MONTHS OVERSENSING WAS REPORTED. NO DETERIORATION OF THE PATIENT'S HEALTH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308993 LINOX SMART SD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 359066

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization