BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1860621 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15158
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    July 25, 2010
    Report Date
    June 30, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S MONITORING SYSTEM DETECTED ANOTHER RED ALERT (HIGH RIGHT VENTRICULAR PACING LEAD IMPEDANCE) IN (B)(4) 2013. NO CALL WAS REQUIRED AS THE INFORMATION HAD ALREADY BEEN REVIEWED BY THE CLINIC.SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIEVED INFORMATION THAT THE PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LABORATORY. THE PATIENT WAS INDUCED INTO VENTRICULAR FIBRILLATION (VF) WHICH WAS DETECTED BY THE DEVICE AND SUCCESSFULLY TERMINATED. NO OUT-OF-RANGE (OOR) IMPEDANCE VALUE WAS REPORTED. THERE WERE NO CHANGES TO THE DEVICE OR COMPETITOR RV DEFIBRILLATION LEAD AT THIS TIME.THE AVAILABLE INFORMATION SUGGESTS THAT THE DEVICE AND COMPETITOR RV DEFIBRILLATION LEAD REMAIN IN-SERVICE.

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THAT THIS DEVICE AND COMPETITOR RV LEAD SYSTEM REMAINS IN-SERVICE. THE EVENT WILL BE REOPENED IF ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE IS RETURNED FOR LABORATORY TESTING.

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT LATITUDE MONITORING SYSTEM DETECTED ANOTHER RED ALERT (HIGH RIGHT VENTRICULAR PACING LEAD IMPEDANCE). THE LOCAL REPRESENTATIVE WAS NOTIFIED AND THE CLINIC HAD ALREADY STARTED REVIEWING THE LATITUDE DATA. SUBSEQUENTLY, BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM THE LOCAL REPRESENTATIVE THAT THE PHYSICIAN PLANS TO CONTINUE MONITORING THE PERFORMANCE OF THE DEVICE/LEAD SYSTEM.

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THAT THIS DEVICE AND COMPETITOR RV LEAD SYSTEM REMAINS IN-SERVICE. THE EVENT WILL BE REOPENED IF ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE IS RETURNED FOR LABORATORY TESTING.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S MONITORING SYSTEM DETECTED ANOTHER RED ALERT (HIGH RIGHT VENTRICULAR PACING LEAD IMPEDANCE) IN (B)(6) 2013.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S MONITORING SYSTEM DETECTED A RED ALERT (HIGH RV PACING LEAD IMPEDANCE) IN (B)(6) 2014. THE STORED DATA WAS REVIEWED BY THE CLINIC AND THE BOSTON SCIENTIFIC LOCAL REPRESENTATIVE WAS NOTIFIED. THE CLINIC NURSE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS) TO REPORT THAT IMPEDANCE MEASUREMENTS DURING PATIENT ISOMETRICS DID NOT REPRODUCE A HIGH RV IMPEDANCE MEASUREMENT. THERE HAS BEEN NO SIGNS OF OVERSENSING WITH THE PATIENT IN THE CLINIC OR IDENTIFIED ON STORED ELECTROGRAMS. THE LAST RECORDED HIGH RV PACING IMPEDANCE OCCURRED IN SEPTEMBER 2013. SINCE THAT TIME, ALL RV IMPEDANCE MEASUREMENT HAVE BEEN IN THE 500 OHM RANGE. TS WAS INFORMED BY THE CLINIC NURSE THAT THE PHYSICIAN PLANS TO CONTINUE MONITORING THE PERFORMANCE OF THIS DEVICE AND COMPETITOR LEAD.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT'S LATITUDE MONITORING SYSTEM DETECTED A RED ALERT (HIGH RIGHT VENTRICULAR PACING LEAD IMPEDANCE). THE PATIENT'S CHRONIC RIGHT VENTRICULAR (RV) LEAD IS A COMPETITOR LEAD. THE LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES AND WAS INFORMED OF THE ALERT. MOST OF THE DAILY MEASUREMENTS HAD BEEN IN THE 500 OHM RANGE. THERE WERE NO EPISODES ASSOCIATED WITH ELECTROGRAM NOISE IDENTIFIED ONE WEEK PRE AND POST ALERT. THE PHYSICIAN WAS CONTACTED AND WAS INFORMED OF THE ALERT. THE PHYSICIAN ASKED WHY THE ALERT NOTIFICATION OCCURRED ON (B)(6) 2010 AND NOT ON (B)(6) 2010 (DETECTION DATE). TECHNICAL SERVICES INFORMED THE PHYSICIAN THAT THE TIME BETWEEN DETECTION AND NOTIFICATION WAS DUE TO HOW THE COMMUNICATION SCHEDULE WAS CONFIGURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R 1860| E102| 6947