BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/16

    MDR report key: 2941801 · Received January 2, 2013

    Report

    Report Number
    1028232-2012-03518
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    November 5, 2012
    Report Date
    December 18, 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

    DURING THE ANALYSIS OF THE LEAD, IT WAS NOTED THAT THE INSULATION WAS DAMAGED BY EXTERNAL FRAYING IN THE AREA OF THE TRICUSPID VALVE. THE LEAD SHOWED A SHORT-CIRCUIT IN THIS ZONE. THESE DAMAGES CAN WITH HIGH PROBABILITY BE REGARDED AS 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, WHICH COULD PROVIDE INFORMATION ON THE SPATIAL RELATIONSHIPS OF THE IMPLANTED SYSTEM IN THE BODY, WERE NOT AVAILABLE FOR ANALYSIS. THE DEFORMATIONS OF THE SHOCK COILS ARE PROBABLY A RESULT OF THE EXPLANTATION PROCESS. THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS.

    Additional Manufacturer Narrative · 1

    OUS MDR.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF 29 MONTHS, A DROP IN IMPEDANCE (<200 OHM) WAS REPORTED. NO DETERIORATION OF THE PATIENT'S STATE OF HEALTH WAS REPORTED. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525 LINOX SD 65/16 ICD LEAD LWS BIOTRONIK SE & CO. KG 350053

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization