BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETROX S 53

    MDR report key: 1052011 · Received May 21, 2008

    Report

    Report Number
    1028232-2008-00526
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    December 13, 2007
    Report Date
    April 23, 2008
    Manufacturer
    BIOTRONIK MBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR. THE MECHANICAL AND ELECTRICAL PROPERTIES OF THE LAND WERE CHECKED DURING THE ANALYSIS. THE ANALYSIS SHOWED DAMAGE TO THE OUTER INSULATION DUE TO INTERNAL FRAYING IN A SPATIALLY LIMITED AREA (4-6 CM DISTAL OF THE LIGATURE). IN ADDITION, THE ELECTRICAL LINE (OUTER CONDUCTOR HELIX) WAS BROKEN AT THIS SPOT. THESE DAMAGE MANIFESTATIONS MUST BE REGARDED AS THE CAUSES OF THE ELECTRICAL PROBLEMS COMPLAINED- ABOUT. THIS DAMAGE MANIFESTATION IS WITH HIGH PROBABILITY THE RESULT OF THE SIMULTANEOUS OCCURRENCE OF STRONG AND EXCESSIVE PRESSURE ON THE LEAD BODY IN THE IMPLANTED STATE. THE CHARACTERISTICS X-RAY IMAGES, INDICATE SUBCLAVIAN CRUSH SYNDROME, I.E., THE JAMMING OF THE LEAD BETWEEN CLAVICLE AND FIRST RIB. THE CUTS AND INSULATION DAMAGES PROXIMAL OF THE LIGATURE ARE PROBABLY DUE TO TE EXPLANTATION. THE ABRASION SIGNS INDICATE FRICTION WITH OTHER LEADS IN THE IMPLANTED STATE. THE ANALYSIS OF THE DAMAGES AT THE LEAD DID NOT SHOW ANY INDICATIONS FOR MANUFACTURING ERRORS OR MATERIAL DEFECTS.

    Description of Event or Problem · 1

    OUS MDR. AFTER AN IMPLANTATION TIME OF ABOUT 18 MONTHS, STRONGLY VACILLATING IMPEDANCE VALUES WERE REPORTED FOR THE ATRIAL LEAD DURING A FOLLOW-UP. IN ADDITION, THERE WAS AN INCREASE IN THE ATRIAL PACING THRESHOLD TO 5.0 V (EXIT BLOCK). THE LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 53 PACER LEAD DTB BIOTRONIK MBH AND CO. 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization