BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETROX S 60

    MDR report key: 1003712 · Received February 15, 2008

    Report

    Report Number
    1028232-2008-00085
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    September 4, 2007
    Report Date
    January 23, 2008
    Manufacturer
    BIOTRONIK GMBH & CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR. THE ELECTRICAL PROPERTIES OF THE LEAD WERE TESTED. NO MANUFACTURING ERROR OR MATERIAL DEFECT COULD BE FOUND DURING THE ANALYSIS. A FRAYING OF THE EXTERNAL INSULATION WAS DETECTED. THIS DAMAGE LED WITH HIGH PROBABILITY TO AN IMPAIRMENT OF THE ELECTRICAL PROPERTIES OF THE LEAD AND AN INCREASE IN THE PACING THRESHOLD DUE TO THIS. THE OBSERVED DAMAGE MANIFESTATION IS CAUSED BY EXCESSIVE PRESSURE LOAD ON THE LEAD BODY. THE LOCATION IN RELATION TO THE LIGATURE AS WELL AS THE CHARACTERISTICS OF THE DAMAGED STRUCTURE OF THE INSULATION SUGGEST EXCESSIVE FRICTION AT THE PACEMAKER HOUSING. DIAGNOSTIC IMAGES OF THE AFFECTED BODY REGION ARE NOT AVAILABLE.

    Description of Event or Problem · 1

    OUS MDR. ARTIFACT-TRIGGERED SENSING OF THE P/S LEAD. INCREASE IN THE PACING THRESHOLD TO 2.8/0.5. DEFECT DUE TO ABRASION (DISTAL). THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 60 PACER LEAD DTB BIOTRONIK GMBH & CO. 350975

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization