BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1862261 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-16282
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 12, 2010
    Report Date
    October 27, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. VISUAL INSPECTION NOTED ALL SEAL PLUGS WERE INTACT, ALL SETSCREWS MOVED FREELY AND THE DEVICE PASSED PIN GAGE TESTING. A REVIEW OF DEVICE MEMORY NOTED THAT ON TWO OCCASIONS THE RV IMPEDANCE DROPPED TO APPROXIMATELY 200 OHMS. A SAVE TO DISK OPERATION WAS ATTEMPTED; HOWEVER, WAS UNSUCCESSFUL. THE PROGRAMMER DISPLAYED A MESSAGE THAT AN UNEXPECTED DISK ERROR WAS ENCOUNTERED AND THAT THE DATA MAY BE CORRUPT; THE SAVE TO DISK DID NOT COMPLETE. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, CRM FOR ANALYSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF FURTHER INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS CURRENTLY UNDERGOING DETAILED ANALYSIS. THIS EVENT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

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    Additional Manufacturer Narrative · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL, WHICH WAS NOT REPRODUCIBLE. IT WAS NOTED THAT THE PATIENT WAS NOT PACEMAKER DEPENDANT, SO NO PACING INHIBITION WAS NOTED. ADDITIONAL EPISODES OF NOISE WERE OBSERVED, WHICH RESULTED IN INAPPROPRIATE ATRIAL TACHYCARDIA RESPONSE (ATR) AND ANTI TACHYCARDIA PACING (ATP). THE PHYSICIAN SUSPECTED THE NOISE WAS DUE TO A HEADER ISSUE. A REVISION PROCEDURE WAS PERFORMED. ON VISUAL INSPECTION, IT WAS NOTED THAT THE LEAD WAS NOT COMPLETELY SEATED IN THE HEADER, BUT WAS STILL TIGHTENED IN THE HEADER. THE LEAD WAS RE-INSERTED IN THE HEADER, AND NO FURTHER EPISODES OF NOISE WERE OBSERVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT ADDITIONAL EPISODES OF NOISE WERE OBSERVED ON THE RV CHANNEL, RESULTING IN THE PATIENT RECEIVING A SHOCK. IT WAS NOTED THAT THERE WERE MULTIPLE EPISODES OF VENTRICULAR FIBRILLATION (VF) DUE TO NOISE. THE IMPEDANCES WERE NOTED TO BE STABLE. THE NOISE WAS ABLE TO BE RECREATED WITH THE 'SEAT-BELT MANEUVER', AS WELL AS HAVING THE PATIENT'S ARM STRAIGHT OUT AND TO THE SIDE. THE DEVICE SENSITIVITY WAS REPROGRAMMED, AND THIS WILL BE DISCUSSED FURTHER WITH THE PHYSICIAN.

    Description of Event or Problem · 1

    THE DEVICE WAS LATER RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT FURTHER EPISODES OF NOISE HAVE BEEN OBSERVED, ALONG WITH FREQUENT INAPPROPRIATE SHOCKS. THE RV LEAD IMPEDANCE HAS DECREASED AS WELL, THUS IT WAS QUESTIONED IF THE LEAD SHOULD BE REPLACED. IT WAS NOTED THAT ANOTHER LEAD REVISION WAS PLANNED, WITH CONSIDERATIONS TO REPLACE THE LEAD AND DEVICE. TS DISCUSSED A POSSIBLE LEAD INSULATION ISSUE AFFECTING JUST THE RATE/SENSE PORTION, BUT THAT IT WAS PHYSICIAN DISCRETION WHETHER TO REPLACE THE ENTIRE LEAD OR JUST DROP A NEW RATE/SENSE LEAD. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED THAT A REVISION PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, IT WAS NOTED THAT ON X-RAY, THE ENTRY POINT OF THE LEAD WAS LOCATED DIRECTLY BENEATH THE PATIENT'S CLAVICLE. IT WAS SUSPECTED THAT BASED UPON THE IMPEDANCE DATA AND THE NOISE, THAT EVIDENCE POINTED IN THE BEGINNING STAGES OF AN INSULATION ISSUE. IT WAS FURTHER NOTED THAT DURING THE PROCEDURE, WHEN ATTEMPTING TO PLACE A NEW RV PACE/SENSE LEAD, ACCESS TO THE VEIN WAS EXTREMELY DIFFICULT, THUS THE PHYSICIAN ELECTED TO IMPLANT A NEW SYSTEM ON THE RIGHT SIDE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention T125| 0185| E102