BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SD 65/18

    MDR report key: 1902818 · Received November 12, 2010

    Report

    Report Number
    1028232-2010-02381
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    May 3, 2010
    Report Date
    October 21, 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 THAT THE ROPE CONDUCTOR TO THE RING ELECTRODE WAS FRACTURED. IN ADDITION, SEVERE DEFORMATION COULD BE SEEN AT THE SHOCK COILS. THESE DAMAGES ARE PROBABLY DUE TO STRONG TENSILE STRESS DURING THE EXPLANTATION. FURTHERMORE, THE ANALYSIS FOUND 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 AT JUST THAT SITE. THE FRAYING OF THE INSULATION REQUIRES AN EXCESSIVE PRESSURE LOAD ON THE LEAD. THE POSITION AND CHARACTERISTICS OF THE FRAYING LEAD TO THE ASSUMPTION OF A SIMULTANEOUS OCCURRENCE OF STRONG PRESSURE OF THE LEAD ONTO THE ICD HOUSING AND EXCESSIVE FRICTION OF THE LEAD AT THE ICD HOUSING. THE ANALYSIS DID NOT DISCOVER ANY MANUFACTURING ERROR OR MATERIAL DEFECT AT THE LEAD.

    Description of Event or Problem · 1

    AFTER AN IMPLANTATION TIME OF ABOUT 40 MONTHS, THIS LEAD WAS EXPLANTED DUE TO ARTIFACTS WITH INAPPROPRIATE SHOCK DELIVERY. NO DETERIORATION OF THE PT'S STATE OF HEALTH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SD 65/18 ICD LEAD LWS BIOTRONIK SE & CO. KG 350054

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization