BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1862131 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-17407
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    July 29, 2010
    Report Date
    February 2, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRINTOUTS FROM THE ASSOCIATED DEVICE WILL BE SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR EVALUATION. AT THIS TIME, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    A TS REPRESENTATIVE REVIEWED THE DATA AND DISCUSSED THAT THE INCREASE IN PACING IMPEDANCES APPEAR TO BE GRADUAL OVER THE PAST YEAR. IT IS POSSIBLE TO SEE THIS INCREASE IN IMPEDANCES WITH A DEFIBRILLATION LEAD THAT IS ONLY PACING, BUT HAS NOT DELIVERED SHOCKS. THE TS REPRESENTATIVE FURTHER DISCUSSED THAT THE PATIENT SHOULD BE FOLLOWED EVERY THREE MONTHS TO KNOW WHEN THE PACING IMPEDANCE BECOMES ABOVE 3, 000 OHMS AS LEAD INTEGRITY CAN NO LONGER BE MONITORED AT THAT POINT. AT THIS TIME, THIS LEAD REMAINS IMPLANTED AND 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A NORMAL FOLLOW UP, IT WAS NOTED THAT THERE HAS BEEN A GRADUAL INCREASE IN PACING IMPEDANCES ON THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD. OVER THE LAST YEAR, THE MEASUREMENTS HAVE INCREASED FROM 818 TO 2616 OHMS. IN ADDITION, THE PACING THRESHOLD HAS ALSO INCREASED FROM 1.2 VOLTS TO 2.8 VOLTS. HOWEVER, SENSING HAS REMAINED NORMAL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    PRINTOUTS WERE SENT TO TS FOR FURTHER EVALUATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 Other