BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETROX S 45

    MDR report key: 3723774 · Received April 3, 2014

    Report

    Report Number
    1028232-2014-01088
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 24, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING ANALYSIS, IT WAS FOUND THAT THE LEAD BODY INSULATION WAS DAMAGED BY CRUSHING APPROXIMATELY 16 CM DISTAL TO THE CONNECTOR PIN. FURTHERMORE, THE INNER COIL LEADS SHOWED A LEAD BREAK AT THIS POSITION. THE CHARACTERISTICS OF THE DAMAGED LEAD BODY STRUCTURE SUGGEST EXCESSIVE MECHANICAL LOAD ON THE LEAD DUE TO SUBCLAVIAN CRUSH SYNDROME. THE LEAD INSULATION SHOWED WEAR 8.5 CM DISTAL TO THE CONNECTOR PIN, AS NOTED IN THE COMPLAINT. THE POSITION AND TYPE OF WEAR SUGGEST A SIMULTANEOUS OCCURRENCE OF GREAT PRESSURE OF THE LEAD ON THE ICD HOUSING AND ALSO THE LEAD RUBBING AGAINST THE ICD HOUSING. THERE WAS NO INDICATION OF A MATERIALS DEFECT OR A MANUFACTURING DEFECT.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION TIME OF ABOUT 49 MONTHS, MUSCLE STIMULATION OF THE PATIENT WAS REPORTED IN THE RIGHT SHOULDER. IN ADDITION, AN INSULATION DEFECT WAS REPORTED ABOVE THE LEAD FIXATION SLEEVE AFTER SURGICALLY OPENING THE DEVICE POCKET. AFTER THE LEAD HAD BEEN SURGICALLY EXPOSED SOME MORE AND EXTRACTED WITHOUT TRAUMA, ANOTHER INSULATION DEFECT WAS SUSPECTED BELOW EFH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202843 SETROX S 45 PACER LEAD NVN BIOTRONIK SE & CO. KG 350973

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization