BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENTROX RV 65

    MDR report key: 1021849 · Received March 28, 2008

    Report

    Report Number
    1028232-2008-00390
    Event Type
    Malfunction
    Date Received
    March 28, 2008
    Date of Event
    October 2, 2007
    Report Date
    February 29, 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

    THE ANALYSIS CHECKED THE MECHANICAL AND ELECTRICAL PROPERTIES OF THE LEAD. IN REGARD TO THE CLINICALLY OBSERVED INCREASE IN THE PACING IMPEDANCE AND THE THRESHOLD, NO DEVIATIONS FROM THE ELECTRICAL SPECIFICATIONS COULD BE FOUND. THERE WERE NO INDICATIONS OF A LEAD FRACTURE. IT CAN BE ASSUMED THAT THE SIGNS OF CUTTING IN THE EXTERNAL INSULATION WERE A RESULT OF THE EXPLANTATION. IN ADDITION, VARIOUS ABRASION SPOTS COULD BE DETECTED AT THE LEAD BODY. A PARTICULARLY PRONOUNCED ABRASION SPOT WAS SITUATED JUST PROXIMAL OF THE LIGATURE. THE GEOMETRY AND CHARACTERISTICS OF THE ABRASION SUGGEST EXCESSIVE FRICTION AT THE HOUSING OF THE ICD. DIAGNOSTIC IMAGES TO CHECK THIS ASSUMPTION WERE NOT AVAILABLE FOR ANALYSIS. NO MFG ERROR OR MATERIAL DEFECT COULD BE FOUND DURING THE ANALYSIS.

    Description of Event or Problem · 1

    THE VENTRICULAR PACING THRESHOLD AND THE IMPEDANCE SHOWED GRADUALLY INCREASING VALUES. FINALLY, AN IMPEDANCE OF >3000 OHM WAS MEASURED. THE DECISION WAS MADE TO REVISE AND REPLACE THE LEAD. THE LEAD COULD BE REMOVED QUICKLY AND WITHOUT PROBLEMS WITH AN EXTRACTION WIRE. THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENTROX RV 65 ICD LEAD LWS BIOTRONIK GMBH AND CO. 348090

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization