BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX TD 65/18

    MDR report key: 1172180 · Received September 18, 2008

    Report

    Report Number
    1028232-2008-01093
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    June 13, 2008
    Report Date
    August 21, 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

    DURING THE ANALYSIS, THE MECHANICAL AND ELECTRICAL PROPERTIES OF THE LEAD WERE TESTED. THE LEAD WAS RETURNED, CUT THROUGH AT 14 CM DISTAL OF THE CONNECTOR PIN. THERE WERE NO DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS AT THE LEAD FRAGMENTS, WHICH COULD BE RELATED TO THE CLINICAL COMPLAINT. IN PARTICULAR, NO DAMAGE TO THE ELECTRICAL INSULATION WAS DETECTED. THE ELECTRICAL CHECK OF THE FRAGMENTS DID NOT SHOW ANY ANOMALIES. THERE WERE NO INDICATIONS OF MATERIAL DEFECTS OR MANUFACTURING ERRORS.

    Description of Event or Problem · 1

    AN INCREASE IN THE PACING THRESHOLD, MULTIPLE PACING LOSSES, AND A DECREASE IN SENSING WERE REPORTED 2 DAYS AFTER THE IMPLANTATION OF THE ICD. THE LEAD WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX TD 65/18 ICD LEAD LWS BIOTRONIK GMBH AND CO. 351338

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization