BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1871157 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-18235
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 9, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL WAS CONTACTED IN AN ATTEMPT TO DETERMINE WHETHER THE ASSOCIATED LEAD IS A BOSTON SCIENTIFIC PRODUCT, HOWERVER, NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION CONFIRMED THE LEAD WAS A BOSTON SCIENTIFIC PRODUCT. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT RECOMMENDED CONTINUED MONITORING OF THE IMPEDANCE. THE PHYSICIAN ELECTED NOT TO PERFORM A REVISION. THIS REPORT WILL BE UPDATED IF MORE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, REVIEW OF DEVICE MEMORY CONFIRMED SEVERAL PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 2,000 OHMS. VISUAL INSPECTION OF THE DEVICE CONFIRMED THE REPORTED LOOSE HEADER. THE HEADER HAD NOT BEEN LIFTED FROM THE DEVICE CASE. AN X-RAY OF THE HEADER NOTED ALL THE HEADER WIRES WERE INTACT, INDICATING THE LOOSE HEADER WAS NOT THE CAUSE OF THE IMPEDANCE ANOMALY. INSPECTION OF THE INSIDE OF THE RV PORT NOTED A SMALL AMOUNT SMALL AMOUNT OF EXCESS HEADER MATERIAL. HOWEVER, FURTHER MICROSCOPIC INSPECTION OF THE HEADER FOUND SEAL RING MARKS WHICH INDICATED THE HAD BEEN FULLY INSERTED INTO THE HEADER. INSPECTION OF THE SETSCREW NOTED NO ANOMALIES. IMPEDANCE MEASUREMENTS WERE PERFORMED WITH PACING LEADS ATTACHED, AND ALL MEASUREMENTS WERE NORMAL. THE DEVICE ALSO PASSED SERIES OF DIAGNOSTIC TESTS THAT VERIFY THE PERFORMANCE OF PACING, SENSING, SHOCKING AND RECORDING FUNCTIONS. ANALYSIS CONCLUDED THE LOOSE HEADER AND EXCESS HEADER MATERIAL WERE NOT THE CAUSE OF THE CLINICALLY OBSERVED HIGH IMPEDANCE OBSERVATION. ANALYSIS COULD NOT DETERMINE THE ROOT CAUSE, AS OBSERVATION COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE HAD RECORDED A PACING IMPEDANCE MEASUREMENT OUT OF RANGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS LATER RECEIVED THAT THE DEVICE HAD RECORDED THREE SINGLE MEASUREMENTS GREATER THAN 2000 OHMS. OTHER DAILY IMPEDANCE MEASUREMENTS WERE STABLE AT APPROXIMATELY 900 OHMS.

    Description of Event or Problem · 1

    AN INVASIVE PROCEDURE WAS PERFORMED AND THE SYSTEM WAS EVALUATED. ALL SETSCREWS WERE PROPERLY SEATED. IT WAS REPORTED THE DEVICE HEADER WAS LOOSE. THIS DEVICE IS INCLUDED IN THE (B)(6), 2009 SUBPECTORAL IMPLANT 2009 ADVISORY POPULATION, AND HAD BEEN IMPLANTED SUBPECTORALLY. LEAD MEASUREMENTS WITH A PACING SYSTEM ANALYZER (PSA) WERE IN THE NORMAL RANGE. THE DEVICE WAS EXPLANTED AND REPLACED, WHILE THE RELATED LEAD REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention