BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2913644 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-17164
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    October 30, 2012
    Report Date
    March 19, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    SHOULD THIS DEVICE BE RETURNED, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS RIGHT VENTRICULAR LEAD DISPLAYED NUMEROUS NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES WERE STORED IN THE ARRHYTHMIA LOG BOOK. ONE EPISODE HAD BEEN TREATED WITH ANTITACHYCARDIA PACING. THE ELECTROGRAM INDICATED THIS WAS NOISE. PROVOCATION MEASUREMENTS COULD NOT REPRODUCE THE NOISE. AS THE PATIENT DOES HEAVY LIFTING FOR HIS JOB, REMOTE MONITORING WAS SET UP. AN X-RAY DID NOT REVEAL ANY ISSUES, HOWEVER SUBSEQUENTLY, AN X-RAY WAS PROVIDED TO AN INTERNAL TECHNICAL SERVICE CONSULTANT. UPON REVIEW OF THE XRAY, TS DETERMINED THAT THE RIGHT VENTRICULAR PACING LEAD HAD NOT BEEN FULLY SEATED INTO THE SET SCREW. IT WAS THOUGHT THIS FINDING WAS THE REASON FOR THE ELECTROGRAM NOISE. AS THE PATIENT DOES NOT REQUIRE PACING, THE NOISE CAUSING OVERSENSING DID NOT RESULT IN ASYSTOLE GREATER THAN TWO SECONDS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. A DECISION WILL BE MADE REGARDING REVISION IN THE NEAR FUTURE.

    Description of Event or Problem · 1

    SUBSEQUENTLY, APPROXIMATELY THIRTEEN MONTHS LATER, A REPLACEMENT PROCEDURE WAS PERFORMED. THIS DEVICE WAS REMOVED AND REPLACED. THERE WAS NO ALLEGATION AGAINST DEVICE PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21014 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1