BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2173849 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-10702
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    June 17, 2011
    Report Date
    August 13, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY A THOROUGH PRODUCT ANALYSIS WAS PERFORMED. AN IS-1 LEAD WAS USED TO DETERMINE THE POSITIONING OF THE IMPLANTED LEADS BY THE MARKS LEFT IN THE LEAD BARREL OF THE RIGHT ATRIAL (RA) CHANNEL BY THE SEALING RINGS OF THE IMPLANTED LEAD. IT WAS SUSPECTED THAT THE RA LEAD MAY NOT BEEN FULLY INSERTED INTO THE LEAD BARREL DURING THE TIME OF IMPLANT WHICH MAY HAVE RESULTED IN THE HIGH RA LEAD IMPEDANCE MEASUREMENTS. ANALYSIS OF THE DEVICE MEMORY CANNOT DETERMINE THE DATE OF OUT OF RANGE LEAD IMPEDANCE MEASUREMENTS, AS THEY HAVE BEEN OVERWRITTEN BY NEWER DATA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    THIS DEVICE WAS SUBSEQUENTLY EXPLANTED AND RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT ATRIAL IMPEDANCE MEASUREMENTS HAD BEEN ON THE RISE SINCE THE LEAD WAS IMPLANTED. THE IMPEDANCE MEASUREMENTS HAVE INCREASED TO GREATER THAN 2000 OHMS. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR 4135| E110