BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX ST 60

    MDR report key: 2000206 · Received February 18, 2011

    Report

    Report Number
    1028232-2011-00308
    Event Type
    Malfunction
    Date Received
    February 18, 2011
    Date of Event
    September 10, 2010
    Report Date
    February 8, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS DISCOVERED THAT THE DISTAL END HAD BEEN PULLED OUT OF THE LEAD. THIS DAMAGE MANIFESTATION REQUIRES EXCESSIVE MECHANICAL STRESS AND IS WITH HIGH PROBABILITY A RESULT OF STRONG TENSILE FORCES DURING THE EXPLANTATION. THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE ELECTRICAL SPECIFICATIONS THAT COULD BE RELATED TO THE HIGH PACING THRESHOLD. NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS WERE FOUND.

    Description of Event or Problem · 1

    AFTER AN IMPLANTATION PERIOD OF ABOUT 38 MONTHS, IT WAS REPORTED THAT, AFTER INITIALLY UNREMARKABLE PACING THRESHOLD AND IMPEDANCE VALUES, A GRADUAL IMPEDANCE INCREASE IN THE VENTRICLE TO >3200 OHM COULD BE SEEN FROM 2009 ON. THIS WAS ASSOCIATED WITH AN INCREASE IN THE PACING THRESHOLD. THE EXACT EXPLANTATION DATE WAS NOT PROVIDED. NO DETERIORATION OF THE PATIENT'S STATE OF HEALTH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX ST 60 28212740 NVZ BIOTRONIK SE & CO. KG 346367

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization