BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1946215 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-22741
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    January 18, 2010
    Report Date
    October 14, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT THERE WAS ONE LATITUDE TRANSMISSION ASSOCIATED WITH A RED ALERT (HIGH SHOCK IMPEDANCE) BUT ALL DAILY MEASUREMENTS (DM) ARE WITHIN NORMAL LIMITS (WITH SOME VARIATIONS). THE PATIENT HAS BEEN SCHEDULED FOR A NONINVASIVE PACING STUDY (NIPS) INCLUDING DELIVERY OF A LOW AND MAXIMUM ENERGY SHOCKS. THE PATIENT WAS PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY AND COMMANDED SHOCKS (LOW AND MAXIMUM ENERGY SHOCKS) WERE DELIVERED. THE RECORDED RV IMPEDANCE MEASUREMENTS WERE NORMAL (71 OHMS). THE PATIENT WAS DISCHARGED AND NO INVASIVE INTERVENTION WAS PLANNED. TECHNICAL SERVICES DISCUSSED HIGH SHOCK IMPEDANCE AND THE POSSIBILITY THAT THE OOR MEASUREMENT WAS IMPACTED BY ELECTROMAGNETIC INTERFERENCE. 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 RECEIVED INFORMATION THAT THE LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES IN (B)(6) 2010 TO DISCUSS SHOCK MEASUREMENTS FOR THIS DEVICE. THE LOCAL REPRESENTATIVE REPORTED THERE WERE TWO THAT WERE ABOVE 100 OHMS IN (B)(6) 2009 AND (B)(6) 2010. THE INDUCTION EPISODE AT THE TIME OF THE PROCEDURE WAS 62 OHMS. TECHNICAL SERVICES EXPLAINED THAT THIS SINGLE COIL LEAD COULD HAVE A HIGHER IMPEDANCE BUT IT IS IN THE TIMEFRAME OF A POSSIBLE LOOSE SET SCREW. THE RIGHT VENTRICULAR (RV) IMPEDANCE WAS STABLE. TECHNICAL SERVICES DISCUSSED THAT THIS COULD BE NORMAL OR A QUESTIONABLE SET SCREW. TECHNICAL SERVICES SUGGESTED AN XRAY TO EVALUATE THE SYSTEM AND THAT THE PHYSICIAN COULD CONTINUE TO MONITOR IF DESIRED. THE DEVICE WAS PROGRAMMED TO PROPER RV TO RV (COIL) CONFIGURATION. THE EMERGENCY ROOM (ER) PHYSICIAN DID OBTAIN A CHEST X-RAY THAT WAS DONE IN AN ANTERIOR-POSTERIOR ORIENTATION WHICH MADE IT VERY DIFFICULT TO SEE A CLEAR PICTURE OF THE HEADER. THE PHYSICIAN SPOKE WITH THE ON-CALL CARDIOLOGIST AND ELECTED TO MONITOR AND FOLLOW UP IN THE OFFICE. NO INTERVENTION WAS UNDERTAKEN. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S LATITUDE MONITORING SYSTEM DETECTED A RED ALERT (HIGH SHOCK IMPEDANCE) IN (B)(6) 2010. THE LOCAL REPRESENTATIVE AND CLINIC NURSE WERE NOTIFIED OF THE ALERT. SUBSEQUENTLY, THE LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT CHECKED THE SHOCK IMPEDANCE AND THE MEASUREMENTS WERE IN THE 82-83 OHM RANGE. NO ELECTROGRAM NOISE OR OUT-OF-RANGE (OOR) MEASUREMENTS WERE RECORDED DURING POCKET MANIPULATION. BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE LOCAL REPRESENTATIVE THAT THIS PATIENT HAS BEEN SCHEDULED FOR AN INVASIVE PROCEDURE TO REPLACE THE RV LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R 4135| 4543| 0180| N119