BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 1942341 · Received December 23, 2010

    Report

    Report Number
    1028232-2010-02872
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    September 2, 2010
    Report Date
    December 13, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD PROPERTIES WERE CHECKED DURING THE ANALYSIS. THE ANALYSIS SHOWED DAMAGE TO THE INSULATION 11 CM DISTAL OF THE CONNECTOR PIN. IN ADDITION, THE INNER CONDUCTOR HELIX WAS BROKEN. THIS DAMAGE MANIFESTATION CAN WITH HIGH PROBABILITY BE REGARDED THE CAUSE FOR THE CLINICAL COMPLAINT. THE OBSERVED DAMAGE MANIFESTATION REQUIRES AN EXCESSIVE MECHANICAL LOAD ON THE LEAD OVER AS LONGER PERIOD OF TIME. THE POSITION AND CHARACTERISTICS OF THE DAMAGES LEAD TO THE ASSUMPTION OF A SIMULTANEOUS OCCURRENCE OF STRONG KINKING AND PRESSURE STRESS AT THE ICD HOUSING. DIAGNOSTIC IMAGES TO CHARACTERIZE THE POSITIONAL RELATIONSHIPS OF THE IMPLANTED SYSTEM WERE NOT AVAILABLE FOR ANALYSIS. THE ANALYSIS WAS UNABLE TO FIND ANY MANUFACTURING ERROR OR MATERIAL DEFECT.

    Description of Event or Problem · 1

    THIS DEVICE WAS EXPLANTED AFTER AN IMPLANTATION TIME OF ABOUT 6 MONTHS, DUE TO OVERSENSING. NO DETERIORATION IN THE PT'S STATE OF HEALTH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX S 65 ICD LEAD LWS BIOTRONIK SE & CO. KG 351333

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization