BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 1882513 · Received October 22, 2010

    Report

    Report Number
    1028232-2010-02198
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    June 11, 2010
    Report Date
    September 22, 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 ANALYSIS OF THE LEAD DETECTED FRAYING OF THE INSULATION 16 CM DISTAL OF THE CONNECTOR PIN, AS WELL AS FRAYING OF THE COATING OF THE ROPE CONDUCTOR TO THE RING ELECTRODE IN THE SAME AREA. THIS DAMAGE MANIFESTATION CAN, WITH HIGH PROBABILITY, BE REGARDED THE CAUSE FOR THE CLINICAL COMPLAINT. FRAYING OF THE INSULATION REQUIRES AN EXCESSIVE MECHANICAL LOAD ON THE LEAD. THE POSITION AND CHARACTERISTICS OF THE FRAYING LEAD TO THE ASSUMPTION OF THE SIMULTANEOUS OCCURRENCE OF STRONG PRESSURE OF THE LEAD ONTO THE ICD HOUSING AND EXCESSIVE FRICTION OF THE LEAD AT THE ICD HOUSING. X-RAY IMAGES OR DIAGNOSTIC IMAGES OF ANY OTHER KIND, WHICH COULD PROVIDE INFO ON THE POSITIONAL RELATIONSHIPS OF THE IMPLANTED SYSTEM IN THE BODY, WERE NOT AVAILABLE FOR ANALYSIS. THE DEFORMATION OF THE OUTER CONDUCTOR HELIX IS PROBABLY A RESULT OF THE EXPLANTATION PROCESS. THE ANALYSIS DID NOT FIND ANY MANUFACTURING ERRORS OR MATERIAL DEFECTS OF THE LEAD.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED DUE TO OVERSENSING AFTER AN IMPLANTATION TIME OF ABOUT 5 MONTHS. NO DETERIORATION OF THE PATIENT'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