BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENTROX RV-S 65

    MDR report key: 1062199 · Received June 13, 2008

    Report

    Report Number
    1028232-2008-00655
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Report Date
    May 21, 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
    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 DETECTED. THIS DAMAGE MANIFESTATION IS, WITH HIGH PROBABILITY, DUE TO THE OCCURRENCE OF STRONG LOCAL PRESSURE LOADS AT 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 HERE 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. DIAGNOSTIC IMAGES OF THE MENTIONED BODY REGION WERE NOT AVAILABLE FOR A FURTHER INVESTIGATION OF THIS SITUATION. THE ABRASION TRACES ON THE LEAD BODIES OF BOTH LEADS ARE PROBABLY DUE TO CONTINUOUS LOCAL FRICTION OF THE LEADS AGAINST EACH OTHER. THE CUTS IN THE OUTER INSULATION AND THE BLOOD TRACES WITHIN THE LEAD KENTROX RV-S ARE PROBABLY DUE TO THE EXPLANTATION PROCEDURE. THE ANALYSIS WAS UNABLE TO FIND ANY MFG ERROR OR MATERIAL DEFECT.

    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. SELOX SR 60, MDR 1028232-2008-00657.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENTROX RV-S 65 ICD LEAD LWS BIOTRONIK GMBH AND CO. 338148

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization