BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2173658 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10971
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 20, 2011
    Report Date
    April 25, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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

    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. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT PACING IMPEDANCE MEASUREMENTS WERE GREATER THAN 2,500 OHMS DURING WEEKLY DAILY MEASUREMENT TESTING. AN IN CLINIC OFFICE INTERROGATION DISPLAYED IMPEDANCE MEASUREMENTS WITHIN ACCEPTABLE LIMITS DURING ISOMETRIC TESTING. NOISE WAS DISPLAYED ON THE NON-BSC RIGHT VENTRICULAR (RV) LEAD, HOWEVER, THE NOISE WAS NOT OVERSENSED. THE DEVICE SYSTEM WAS TO BE MONITORED. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT IMPLANTED WITH THIS DEVICE SYSTEM WAS BROUGHT INTO THE CLINIC FOR DEVICE TESTING. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE WAS ABLE TO REPRODUCE THE INCREASED RV PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. DURING ISOMETRIC TESTING, NOISE WAS OBSERVED, HOWEVER, IT WAS NOT BEING OVERSENSED. ALL OTHER LEAD MEASUREMENTS WERE WITHIN ACCEPTABLE LIMITS. A REVISION PROCEDURE WAS PERFORMED, SUSPECTING THE NON-BSC RV LEAD TO BE FRACTURED AND THE NON- BSC RV LEAD WAS REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED FOR A THERAPY UPGRADE REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 69 YR E102