BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENTROX A+ 75/15 STEROID

    MDR report key: 1052010 · Received May 21, 2008

    Report

    Report Number
    1028232-2008-00521
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    December 8, 2007
    Report Date
    April 22, 2008
    Manufacturer
    BIOTRONIK, GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR. AS PART OF THE ANALYSIS OF THE LEAD, IT WAS NOTED THAT THE INNER INSULATION OF THE LEAD BODY WAS DAMAGED. HOWEVER, NO SHORT CIRCUITS BETWEEN THE VARIOUS CONNECTOR PLUG POTENTIALS OR DEVIATIONS FROM THE ELECTRICAL SPECIFICATIONS WERE FOUND THAT COULD BE RELATED TO THE CLINICAL COMPLAINT, NOT EVEN UNDER PRESSURE AND CHANGING MECHANICAL LOAD. THE OBSERVED DAMAGE MANIFESTATION REQUIRES EXCESSIVE PRESSURE STRESS EXERTED ON THE LEAD BODY OVER A LONGER PERIOD OF TIME. THE POSITION IN RELATION TO THE LIGATURE AND THE CHARACTERISTICS OF THE DAMAGED STRUCTURE OF THE INNER INSULATION LEAD TO THE ASSUMPTION OF INCREASED MECHANICAL STRESS TO THE LEAD BY THE SUBCLAVIAN CRUSH SYNDROME (I.E. JAMMING OF THE LEAD BODY BETWEEN THE CLAVICLE AND THE FIRST RIB IN THE IMPLANTED STATE). DIAGNOSTIC IMAGES OF THE MENTIONED BODY REGION WERE NOT AVAILABLE. WE WERE UNABLE TO FIND A MANUFACTURING ERROR OR MATERIAL DEFECT.

    Description of Event or Problem · 1

    OUS MDR. INAPPROPRIATE VF EPISODES WERE REPORTED AFTER AN IMPLANTATION TIME OF ABOUT 9 MONTHS. IMPLANT DATE IS APPROXIMATE CF. ALSO REMOVED WAS A LEXOS A+/T, MDR 1028232-2008-00522.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENTROX A+ 75/15 STEROID ICD LEAD LWS BIOTRONIK, GMBH AND CO. 341436

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization