BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX TD 65/16

    MDR report key: 1122226 · Received August 8, 2008

    Report

    Report Number
    1028232-2008-00845
    Event Type
    Malfunction
    Date Received
    August 8, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 15, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    OVER THE PAST MONTH THE IMPEDANCE OF THE LEAD HAS BEEN STEADILY INCREASING FROM APPROX 600 OHM TO APPROX 2400 OHMS ON HOME MONITORING REPORTS. THEY BROUGHT THE PT IN TO TEST THE LEAD, AND FOUND THE THRESHOLD HAD INCREASED FROM 0.6MV TO 3.5MV AS WELL. PROVOCATIVE TESTING DID NOT CREATE A CHANGE IN IMPEDANCE, THEY OPTED TO REOPEN THE POCKET AND TEST THE LEAD DIRECTLY. DURING THE PROCEDURE, THEY DETERMINED THE PIN CONDUCTOR IMPEDANCE WAS APPROX 2300 OHMS, WHEREAS THE RING CONDUCTOR WAS APPROX 400 OHMS. THEY CAPPED THE PACE/SENSE PORTION OF THE LEAD AND PLACED A NEW P/S LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX TD 65/16 ICD LEAD LWS BIOTRONIK GMBH AND CO. 351337

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization