BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1864249 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16373
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 4, 2010
    Report Date
    August 30, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS HOSPITALIZED AND THE ICD WAS PROGRAMMED TO TACHYCARDIA THERAPY OFF AND VENTRICULAR SENSING WAS INCREASED TO AVOID THE OVERSENSING. A REVISION WILL BE PERFORMED AT A FUTURE DATE. THE ANALYSIS OF THE ELECTROCARDIOGRAMS IS CURRENTLY ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS THOROUGHLY ANALYZED. VISUAL INSPECTION NOTED THAT THERE WERE SETSCREW MARKS ON ALL TERMINAL PINS. THERE WAS A CUT FOUND IN THE TRILUMEN INSULATION THAT WENT TO THE HIGH VOLTAGE LUMEN. THE RATE/SENSE LUMEN WAS INTACT. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. NO OTHER ANOMALIES WERE FOUND. LABORATORY ANALYSIS COULD NOT CONFIRM THE FIELD OBSERVATIONS OF NOISE, OVERSENSING AND PACING INHIBITION. THIS LEAD WAS FOUND TO BE ELECTRICALLY CONTINUOUS AND CAPABLE OF DELIVERY THERAPY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD RECORDED MANY NON-SUSTAINED EPISODES FROM APPEARED TO BE NOISE OVERSENSING ON THE VENTRICULAR CHANNEL. THE OVERSENSING HAD RESULTED IN PACING INHIBITION FOR MORE THAN TWO SECONDS AND THIS PATIENT IS PACEMAKER DEPENDENT. IN ADDITION, IT ALSO APPEARED THAT VENTRICULAR SIGNALS WERE BEING OVERSENSED ON THE ATRIAL CHANNEL. THE RIGHT ATRIAL (RA) LEAD WAS POSITIONED INFERIOR IN THE ATRIUM WHILE THE RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS PLACED HIGH IN THE SEPTUM OF THE VENTRICLE DUE TO THE PATIENT'S TISSUE. IT IS SUSPECTED THAT THE TWO LEADS ARE COMING IN CONTACT WITH ONE ANOTHER. NO ADVERSE PATIENT EFFECTS WERE EXPERIENCED BY THIS PATIENT. THE ELECTROCARDIOGRAMS WERE SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    A TS REPRESENTATIVE REVIEWED THE ELECTROCARDIOGRAMS AND DISCUSSED THAT THE NOISE OBSERVED ON BOTH THE VENTRICULAR AND SHOCK CHANNELS APPEARED TO BE DUE TO ELECTROMAGNETIC INTERFERENCE (EMI) RATHER THAT LEAD ON LEAD CONTACT. IT WAS SUGGESTED TO ASK THE PATIENT WHAT THEY WERE DOING AT THE TIME THE EPISODES HAD OCCURRED TO ATTEMPT TO TROUBLESHOOT WHAT CAUSED THE EMI. IT WAS ALSO DISCUSSED THAT IF A REVISION IS TO BE PERFORMED, THE CONNECTIONS SHOULD ALSO BE EVALUATED TO RULE OUT THIS AS A POSSIBLE NOISE SOURCE. THE PATIENT WAS HOSPITALIZED AND A REVISION WILL BE PERFORMED AT A LATER DATE. THE ICD WAS REPROGRAMMED TO TACHYCARDIA THERAPY OFF AND THE VENTRICULAR SENSING WAS INCREASED TO AVOID THE OVERSENSING. AT A LATER DATE, IT WAS REPORTED THAT THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS SUCCESSFULLY REPLACED AND WAS RETURNED FOR LABORATORY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1