BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX SR 60

    MDR report key: 1062196 · Received June 13, 2008

    Report

    Report Number
    1028232-2008-00657
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Report Date
    May 21, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS OF THE LEADS TESTED THE MECHANICAL AND ELECTRICAL PROPERTIES. THE SELOX SR SHOWED A DEFORMATION (SQUASHING) OF THE OUTER HELIX AND A CONDUCTOR FRACTURE OF THE INNER CONDUCTOR HELIX ABOUT 2 CM DISTAL OF THE LIGATURE. THIS DAMAGE MUST BE REGARDED THE CAUSE OF THE SUDDEN INCREASE IN THE PACING IMPEDANCE REPORTED ABOUT IN THE COMPLAINT. FURTHERMORE, DAMAGE TO THE INNER INSULATION JUST DISTAL FROM THIS SPOT COULD BE SEEN. THIS DAMAGE MANIFESTATION IS, WITH HIGH PROBABILITY, DUE TO THE OCCURRENCE OF STRONG LOCAL PRESSURE LOADS ON THE LEAD BODY. THE CLOSE VICINITY OF THE FRACTURE OF THE INNER CONDUCTOR HELIX TO THE INTRODUCER AID (EFH) AND THE CHARACTERISTICS OF THE DAMAGE MANIFESTATION LEAD TO THE ASSUMPTION THAT THE LEAD WAS CLAMPED BETWEEN THE EFH AND THE BONES. JAMMING OF THE LEAD BETWEEN THE CLAVICLE AND THE FIRST RIB (SUBCLAVIAN CRUSH SYNDROME) SHOULD BE CONSIDERED. DUE TO THE DYNAMIC STRESS ON THE CLAMPED LEAD EXERTED WHEN THE PT IS MOVING, ABRASION TRACES FORMED, AND DUE TO EXCESSIVE REVERSED BENDING, PRESSURE AND PULLING STRESSES, THE INTERNAL HELIX BROKE.

    Description of Event or Problem · 1

    OUS MDR. A SUDDEN INCREASE IN THE LEAD IMPEDANCE TO ABOUT 3 KOHM WITH SUSPICION OF LEAD FRACTURE WAS REPORTED AFTER AN IMPLANTATION TIME OF ABOUT 6 WEEKS. THE LEADS AND THE ICD WERE EXPLANTED. ALSO REMOVED: LEXOS VR-T, MDR 1028232-2008-00656. KENTROX RV-S 65, MDR 1028232-2008-00655.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX SR 60 PACER LEAD DTB BIOTRONIK GMBH AND CO. 343082

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization