BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 1250872 · Received November 26, 2008

    Report

    Report Number
    1028232-2008-01544
    Event Type
    Malfunction
    Date Received
    November 26, 2008
    Report Date
    October 31, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS CHECKED THE MECHANICAL AND ELECTRICAL PROPERTIES OF THE LEAD. THERE WERE NO DEVIATIONS FROM THE TECHNICIAN SPECIFICATIONS THAT COULD BE RELATED TO THE CLINICAL COMPLAINT. THE CUTS IN THE OUTER INSULATION AND THE DEFORMATION OF THE SHOCK COIL ARE MOST LIKELY A RESULT OF THE EXPLANTATION PROCEDURE. THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS.

    Description of Event or Problem · 1

    OUS MDR. SENSING DISTURBANCES WERE REPORTED. THE IMPLANTATION/EXPLANTATION AND EVENT DATES WERE NOT AVAILABLE. THE LEAD WAS EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization