BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX SR 53

    MDR report key: 1301787 · Received December 4, 2008

    Report

    Report Number
    1028232-2008-01582
    Event Type
    Malfunction
    Date Received
    December 4, 2008
    Date of Event
    June 30, 2008
    Report Date
    November 4, 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 SELOX SR SHOWED A DEFORMATION (SQUASHING) OF THE INSULATION AND A BROKEN CONDUCTOR OF THE INNER CONDUCTOR COIL ABOUT 2 CM DISTAL OF THE LIGATURE. THIS DAMAGE MUST BE REGARDED AS THE CAUSE FOR THE SUDDEN RISE AN PACING IMPEDANCE REPORTED IN THE COMPLAINT. THIS DAMAGE MANIFESTATION IS WITH HIGH PROBABILITY DUE TO THE OCCURRENCE OF A STRONG LOCAL PRESSURE LOAD ON THE LEAD BODY. THE IMMEDIATE VICINITY OF THE FRACTURE OF THE INNER CONDUCTOR COIL TO THE LEAD INTRODUCTION AID (EFH) AND THE CHARACTERISTICS OF THE DAMAGE MANIFESTATION LEAD TO THE ASSUMPTION THAT THE LEAD WAS CLAMPED BETWEEN THE EFH AND THE BONE. JAMMING OF THE LEAD BETWEEN THE CLAVICLE AND THE FIRST RIB ("SUBCLAVIAN CRUSH SYNDROME") SHOULD BE CONSIDERED. THE DYNAMIC STRESS, WHEN THE PT MOVES, ON THE CLAMPED-IN LEAD LED TO ABRASION TRACES, AND THE EXCESSIVE REVERSE BENDING, PRESSURE AND TENSILE STRESSES LED TO A FRACTURE OF THE INNER COIL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO US THAT THE LEAD SHOWED AN IMPEDANCE VALUE >3000 OHM IN THE BATTERY/LEAD TELEMETRY. AN EXPLANTATION WAS PERFORMED. THE LEAD HAD BEEN IMPLANTED IN 2004. THE EXACT DATE OF THE IMPLANTATION WAS NOT MENTIONED TO US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX SR 53 PACER LEAD DTB BIOTRONIK GMBH AND CO. 346368

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization