BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX ST 60

    MDR report key: 1056971 · Received June 4, 2008

    Report

    Report Number
    1028232-2008-00617
    Event Type
    Malfunction
    Date Received
    June 4, 2008
    Report Date
    May 8, 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

    OUS MDR. THE ANALYSIS CHECKED THE MECHANICAL AND ELECTRICAL PROPERTIES OF THE LEAD. THERE WERE NO DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS IN REGARD TO THE ELECTRICAL PROPERTIES OF THE LEAD. THE DAMAGES AT THE OUTER INSULATION PROBABLY STEM FROM THE EXPLANTATION. THE REMAINS OF THE PRIMARY EFH AND THE SECOND EFH WERE ANALYZED. THE ANALYSIS OF THE DAMAGE DID NOT RESULT IN ANY INDICATIONS OF MANUFACTURING ERRORS OR MATERIAL DEFECTS. BASED ON THE ANALYSIS RESULTS, NO FREE-OF-CHARGE REPLACEMENT CAN BE OFFERED.

    Description of Event or Problem · 1

    OUS MDR. AN EXIT BLOCK WAS REPORTED AFTER AN IMPLANTATION TIME OF ABOUT 6 WEEKS. A TEAR IN THE SLEEVE WAS ALSO COMPLAINED ABOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX ST 60 PACER LEAD DTB BIOTRONIK GMBH AND CO. 346367

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization