BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3211085 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07461
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    January 20, 2013
    Report Date
    November 15, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE SYSTEM REMAINS IMPLANTED AND 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 SUBSEQUENTLY EXPLANTED AND RETURNED. THIS PRODUCT ISSUE WILL BE UPDATED WHEN DEVICE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED NOTING AN INCREASED FREQUENCY OF RED ALERTS FOR IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS WITH THIS RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS BROUGHT IN FOR FOLLOW UP AND CURRENT IMPEDANCE WAS 659-720 OHMS. ISOMETRICS DID NOT PRODUCE ANY NOISE OR OUT OF RANGE MEASUREMENTS AND AN X-RAY DID NOT IDENTIFY ANY SYSTEM ISSUES. THE CALLER ALSO REPORTED A MEDICAL RESONANCE IMAGING (MRI) WAS PERFORMED. THE PATIENT DOES HAVE A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) MACHINE AT HOME NEAR HIS BEDSIDE AND THE CALLER WAS INQUIRING IF THE MACHINE COULD BE INTERFERING WITH THE IMPEDANCE MEASUREMENTS. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DOES NOT EXPECT THAT THE CPAP MACHINE COULD BE THE CAUSE, BUT THE CONSULTANT WILL DISCUSS THIS FURTHER WITH OTHER CONSULTANTS. IT IS A POSSIBILITY THAT THE DEDICATED BIPOLAR RV LEAD MAY BE A SPECIAL FACTOR WITH CPAP MACHINES AND IMPEDANCE MEASUREMENTS WHICH MIGHT EXPLAIN WHY OTHER IMPEDANCE MEASUREMENTS HAVE NOT BEEN OUT OF RANGE. THE CONSULTANT SUGGESTED PERFORMING A MEMORY DUMP FOR ENGINEERING TO ANALYZE AS ONE HAS NOT BEEN PERFORMED AND TROUBLESHOOTING HAS NOT REVEALED THE CAUSE OF THE CONTINUED RED ALERTS. A DATA DOWNLOAD WAS PERFORMED AND THE RESULTS WERE COMMUNICATED TO THE CALLER. THE CONSULTANT ADVISED THAT THE RECORDED RV LEAD IMPEDANCES ARE INDICATIVE OF A CONDUCTOR FRACTURE AND/OR A CONNECTION ISSUE. THE DEVICE REMAINS IN SERVICE AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE RED ALERT WAS RECEIVED FROM THIS SYSTEM DUE TO HIGH RIGHT VENTRICULAR (RV) PACING LEAD IMPEDANCE. THE RV LEAD IS COMPETITIVE LEAD. THE CALLER WANTED TO PROGRAM OFF THE RED ALERTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311186 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR 6947| E102