BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART SD 65/16

    MDR report key: 2942139 · Received December 27, 2012

    Report

    Report Number
    1028232-2012-03517
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    November 23, 2012
    Report Date
    December 14, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR.

    Additional Manufacturer Narrative · 1

    DURING THE ANALYSIS OF THE LEAD IT WAS NOTED THAT THE INSULATION WAS DAMAGED BY FRAYING IN THE AREA OF THE HEART VALVES. A CONDUCTOR FRACTURE OF THE RING ELECTRODE WAS FOUND IN THIS AREA. THIS DAMAGE CAN WITH HIGH PROBABILITY BE REGARDED AS THE CAUSE FOR THE CLINICAL COMPLAINT. THE OBSERVED DAMAGE MANIFESTATION REQUIRES STRESS ON THE LEAD DURING A LONGER PERIOD OF TIME. THE POSITION AND CHARACTERISTIC OF THE DAMAGE LEAD TO THE ASSUMPTION OF SIGNIFICANT MECHANICAL STRESS ON THE LEAD. X-RAY IMAGES OR DIAGNOSTIC IMAGES OF ANY OTHER KIND, WHICH COULD PROVIDE INFORMATION ON THE SPATIAL RELATIONSHIPS OF THE IMPLANTED SYSTEM IN THE BODY, WERE NOT AVAILABLE FOR ANALYSIS. FURTHER DAMAGE OF THE LEAD IS PROBABLY A RESULT OF THE EXPLANTATION PROCESS. THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF 23 MONTHS, INAPPROPRIATE SHOCK DELIVERIES WERE REPORTED. NO DETERIORATION OF THE PT'S STATE OF HEALTH WAS REPORTED. THE LEAD WAS EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization