BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 60

    MDR report key: 1151387 · Received September 4, 2008

    Report

    Report Number
    1028232-2008-01076
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    April 16, 2008
    Report Date
    August 8, 2008
    Manufacturer
    BIOTRONIK,GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR. THE ANALYSIS EXAMINED THE MECHANICAL AND ELECTRICAL PROPERTIES OF THE LEAD. THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS. THE CUTS IN THE LEAD BODY PROBABLY STEM FROM THE EXPLANTATION PROCESS. THE FOLLOW-UP DATA WERE ANALYZED. PACING SPIKES COULD BE OBSERVED IN THE ECG WITH MARKERS DURING A SENSING TEST, BUT THERE WAS NO STIMULATION RESPONSE WHEN PACING WITH 3.6V. FURTHERMORE, LOWERED R WAVES OF >6 MV COULD BE DETECTED INTERMITTENTLY IN THE R-WAVE TREND. IN THE TREND OF THE PACING IMPEDANCE, AN INCREASE OF THE IMPEDANCE TO >3000 OHM WAS DOCUMENTED IN 2008. IN SUMMARY, THE ANALYSIS OF THE LEAD AND THE PACEMAKER PROVIDED NO INDICATION FOR A DEVICE DEFECT. THERE WERE NO DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS THAT COULD BE RELATED TO THE CLINICAL COMPLAINT. THE LOW R-WAVE AMPLITUDE AND THE HIGH VENTRICULAR IMPEDANCE POINT TO THE POSSIBLE INTERMITTENT CONTACT BETWEEN PACEMAKER - LEAD - MYOCARDIUM.

    Description of Event or Problem · 1

    OUS MDR. AN INTERMITTENT EXIT BLOCK IN THE VENTRICLE WAS REPORTED TWO DAYS AFTER THE IMPLANTATION. AS PROPHYLAXIS, THE LEAD WAS EXCHANGED TOGETHER WITH THE PACEMAKER. ALSO REMOVED: PHILOS II DR, MDR 1028232-2008-01075.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization