BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX S 65

    MDR report key: 2052448 · Received March 15, 2011

    Report

    Report Number
    1028232-2011-00561
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    December 6, 2010
    Report Date
    March 3, 2011
    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

    DURING THE ANALYSIS OF THE LEAD, FRAYING OF THE INSULATION 14 CM DISTAL OF THE CONNECTOR PIN AND FRAYING OF THE COATING OF THE ROPE CONDUCTOR TO THE RING ELECTRODE IN THE SAME AREA WERE DETECTED. THIS DAMAGE MANIFESTATION CAN, WITH HIGH PROBABILITY, BE REGARDED THE CAUSE FOR THE CLINICAL COMPLAINT. THE FRAYING OF THE INSULATION REQUIRES EXCESSIVE MECHANICAL STRESS 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 DETECT A MFG ERROR OR MATERIAL DEFECT AT THE LEAD.

    Description of Event or Problem · 1

    AFTER AN IMPLANTATION TIME OF ABOUT 13 MONTHS, OVERSENSING WITH SHOCK DELIVERIES WAS REPORTED AND THIS LEAD WAS EXPLANTED. THERE WERE NO OTHER ADVERSE PT EFFECTS 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