BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 7619268 · Received June 20, 2018

    Report

    Report Number
    2124215-2018-09059
    Event Type
    Malfunction
    Date Received
    June 20, 2018
    Date of Event
    November 22, 2017
    Report Date
    May 15, 2018
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073/S043
    Removal / Correction Number
    N/A¿INTERNATIONAL ONLY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 AN INCREASE IN SHOCK IMPEDANCE MEASUREMENTS WHERE NOTED WHEN IT COMES TO THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). A REVIEW BY BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) NOTED THE SHOCK IMPEDANCE TREND SINCE IMPLANT SHOWED THE GRADUAL INCREASE FOR SINGLE COIL LEAD WHAT WOULD BE EXPECTED. TS DISCUSSED POSSIBLE CAUSES FOR THE CHANGE IN SHOCK VALUES AND NOTED TO PERFORM TROUBLESHOOTING TO DETERMINE THE ROOT CAUSE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION NOTED THAT THE VALUES OF THE SHOCK IMPEDANCE MEASUREMENTS HAD REACHED > 125 OHMS. A REQUEST FOR FURTHER REVIEW WAS REQUESTED AS WELL AS NEXT STEPS. TS DISCUSSED DOING ADDITIONAL TESTING SUCH AS ISOMETRICS, POCKET MANIPULATION, VALSALVA WHILE CAREFULLY MONITORING SHOCK IMPEDANCE ELECTROCARDIOGRAMS. BASED ON THE WHAT THE TESTING REVEALED TS DISCUSSED THE NEXT STEPS TO BE TAKEN. TS NOTED ANOTHER UNANSWERED QUESTION WAS WHETHER THIS CONDITION COULD BE RELATED TO THE PATIENTS¿ HEALTH CHANGE, MEDICATION CHANGE AND WANTED CONFIRMATION. TS NOTED THAT BASED ON THE VALUE AFTER THE MAX SHOCK DELIVERY THE NEXT STEP WOULD BE TO KEEP MONITORING ( IMPEDANCE VALUE < 130 OHMS ) OR REPLACE THE LEAD IF DELIVERED IMPEDANCE VALUE IS > 130 OHMS. ADDITIONAL INFORMATION NOTED THAT NO FURTHER CHANGES WERE MADE TO THE SYSTEM AS THE PATIENT WAS WEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462020 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 0181| G173