BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911932 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16867
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 1, 2012
    Report Date
    July 4, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS AVAILABLE AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT'S HOME MONITORING EQUIPMENT DETECTED HIGH,OUT-OF-RANGE (OOR), SHOCK LEAD IMPEDANCE MEASUREMENTS ON THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. REVIEW OF DATA SHOWED THAT THE SHOCK LEAD IMPEDANCE MEASUREMENTS HAD BEEN IN THE 60 OHM RANGE AND THEN JUMPED TO > 200 OHMS; ALL OTHER MEASUREMENTS WERE STABLE AND STORED EPISODES WERE NONSUSTAINED VENTRICULAR TACHYCARDIA. THE FIELD REPRESENTATIVE CALLED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND REPORTED THAT A CLINIC EVALUATION WAS DONE, AND IN BOTH THE TRIAD AND RV COIL TO RA COIL CONFIGURATIONS MEASUREMENTS YIELDED > 125 OHMS. IN THE RV COIL TO CAN CONFIGURATION THE MEASUREMENT WAS 85 OHMS. A MEMORY DUMP AND SAVE TO DISK WERE PERFORMED. THE RESULTS SHOWED THAT WITH BOTH THE DAILY MEASUREMENT AND THE COMMANDED SHOCK LEAD IMPEDANCE TESTING, THE VALUES IN THE RV COIL TO RA COIL AND THE RA COIL TO CAN WERE OOR, WHILE THE VALUES OF RV COIL TO CAN WERE WITHIN NORMAL LIMITS. TS DISCUSSED DEFIBRILLATION THRESHOLD (DFT) TESTING BE DONE IN THE RV COIL TO CAN CONFIGURATION AND IF ACCEPTABLE MARGINS ARE NOTED, THEN WOULD RECOMMEND PROGRAMMING TO THAT VECTOR. THE FIELD REPRESENTATIVE WAS GOING TO DISCUSS THE FINDINGS WITH THE PATIENT'S PHYSICIAN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE SHOCK LEAD IMPEDANCE REMAINS OUT OF RANGE FOR THIS SYSTEM. THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS AND THE PLAN IS TO CONTINUE TO MONITOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN DID NOT WANT TO PURSUE DFT TESTING AT THIS TIME. NO REPROGRAMMING WAS DONE AND NO SURGICAL INTERVENTION HAS OCCURRED. THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS AND THE PHYSICIAN PLANS TO MONITOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16460 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR 0184| T175| E161