BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2942518 · Received February 4, 2013

    Report

    Report Number
    2124215-2013-02440
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    December 19, 2012
    Report Date
    June 19, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED SEVEN MONTHS FOLLOWING THE INITIAL OBSERVATIONS STATING THAT THE LATITUDE RED ALERTS WERE STILL BEING GENERATED DUE TO HIGH RIGHT VENTRICULAR (RV) PACING LEAD IMPEDANCE MEASUREMENTS. THERE ARE NO EVENTS IN THE LOGBOOK SHOWING ANY TYPE OF NOISE AND THE CALLER REPORTED THAT THE LAST TIME THIS HAPPENED, THE PATIENT WAS BROUGHT INTO THE CLINIC AND THEY COULD NOT REPRODUCE ANY OUT OF RANGE MEASUREMENTS OR ANY NOISE WITH ISOMETRICS. THE CALLER WILL DISCUSS THE CONTINUED CLINICAL OBSERVATIONS WITH THIS PATIENT'S PHYSICIAN. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT REVIEWED THE DAILY MEASUREMENTS AND DISCUSSED ADDITIONAL TESTING TO CHECK FOR NOISE. NO NOISE WAS OBSERVED ON THE STORED ELECTROGRAMS (EGM) OR THE PRESENTING EGM. ADDITIONALLY, THERE HAVE BEEN NO FURTHER RED ALERTS FOR HIGH RV PACE IMPEDANCE. THE PHYSICIAN WILL CONTINUE TO MONITOR THIS PATIENT. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED OVER FIVE YEARS LATER FOR AN UNSPECIFIED REASON. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE RED ALERT WAS GENERATED FROM THIS SYSTEM DUE TO HIGH RIGHT VENTRICULAR (RV) PACING LEAD IMPEDANCE MEASUREMENTS. THIS PATIENT'S SYSTEM CONSISTS OF A BOSTON SCIENTIFIC DEVICE AND A COMPETITIVE RV LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46272 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 7231| E110| 6947| 4470