BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 6935981 · Received October 10, 2017

    Report

    Report Number
    2124215-2017-18240
    Event Type
    Injury
    Date Received
    October 10, 2017
    Date of Event
    September 29, 2015
    Report Date
    August 5, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P910073/S043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE FIELD REPRESENTATIVE WAS CONTACTED TO INQUIRE IF FURTHER TESTING HAS BEEN PERFORMED OR SCHEDULED. THE FIELD REPRESENTATIVE CONFIRMED TESTING HAS NOT BEEN PERFORMED YET AND WAS NOT AWARE OF WHEN THE PATIENT WOULD BE SCHEDULED FOR ADDITIONAL TESTING. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION OCTOBER 2017 THAT THE RIGHT VENTRICULAR (RV) SHOCK LEAD IMPEDANCE MEASUREMENTS HAVE BEEN GRADUALLY INCREASING OVER THE LAST TWO YEARS. NOW, IMPEDANCES ARE AROUND 150 OHMS. THE LEAD HAS BEEN IMPLANTED FOR TEN YEARS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED CHECKING OTHER VECTORS AND PERFORMING A 1:1 JOULE SHOCK TO DETERMINE DELIVERED SHOCK IMPEDANCES AND THEN COMPARE THAT TO THE DAILY MEASUREMENTS AND MANUAL SHOCK IMPEDANCE TEST. ADDITIONAL INFORMATION WAS RECEIVED THAT NON-INVASIVE PROGRAMMED STIMULATION (NIPS)/DEFIBRILLATION THRESHOLD (DFT) TESTING WAS COMPLETED WITH THE PATIENT. THE SHOCK IMPEDANCE AT IMPLANT WAS 55 OHMS AND OVER THE PAST YEAR HAD BEEN TRENDING IN THE LOW 100-125 OHM RANGE. THE PHYSICIAN WANTED TO CONFIRM WITH DELIVERED SHOCKS WHAT THE IMPEDANCE WAS. IMPEDANCES WITH A 1.1 JOULE SHOCK WERE 75 OHMS AND WITH A 31 JOULE SHOCK, THEY WERE 95 OHMS. THE PHYSICIAN WAS SATISFIED WITH THESE MEASUREMENTS. THE SHOCK LEAD IMPEDANCE TEST FOLLOWING SHOWED IMPEDANCES BETWEEN 108-111 OHMS. ALL LEAD VALUES WERE NOTED TO BE STABLE, BUT A BREAKDOWN OF THE VECTORS WAS NOTED TO BE HIGHER. THE DEVICE AND RV LEAD REMAIN IN SERVICE. THE FIELD REPRESENTATIVE WAS CONTACTED TO INQUIRE IF FURTHER TESTING HAS BEEN PERFORMED OR SCHEDULED. THE FIELD REPRESENTATIVE CONFIRMED TESTING HAS NOT BEEN PERFORMED YET AND WAS NOT AWARE OF WHEN THE PATIENT WOULD BE SCHEDULED FOR ADDITIONAL TESTING. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. SUBSEQUENTLY, THE BOSTON SCIENTIFIC SALES REPRESENTATIVE REPORTED IN JUNE 2019 THAT THE CHRONIC RV IS EXHIBITING ELECTROGRAM NOISE ASSOCIATED WITH PACING INHIBITION. THESE OBSERVATIONS ARE REPRODUCIBLE DURING IN-CLINIC DEVICE CHECK. THE SALES REPRESENTATIVE COMMENTED THAT PACING INHIBITION FOR GREATER THAN 2 SECONDS IS UNKNOWN. ADDITIONALLY, THE SALES REPRESENTATIVE REPORTED THAT SHOCK IMPEDANCE MEASUREMENTS HAVE INCREASED FROM 2017. A COMMANDED SHOCK IN 2017 WAS 75 OHMS AND THE MOST RECENT SHOCK IMPEDANCE IS NOW 122 OHMS. THE PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY LABORATORY ON JUNE 4, 2019. THE ENTIRE CHRONIC IMPLANTED SYSTEM WAS EXPLANTED. A REPLACEMENT DEVICE AND LEAD SYSTEM WERE IMPLANTED. HOWEVER, FOLLOWING EXTRACTION OF THE CHRONIC LV LEAD DUE TO SUBOPTIMAL MEASUREMENTS, ATTEMPTS TO CANNULATE THE CORONARY SINUS OSTIUM WAS UNSUCCESSFUL. A CORONARY SINUS DISSECTION WAS IDENTIFIED. NO FURTHER CANNULATIONS WERE ATTEMPTED, AND THE LV PORT OF THE REPLACEMENT DEVICE WAS PLUG. THE PATIENT MAY BE SCHEDULED FOR AN LV LEAD IMPLANT ON A FUTURE DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NON-INVASIVE PROGRAMMED STIMULATION (NIPS)/DEFIBRILLATION THRESHOLD (DFT) TESTING WAS COMPLETED WITH THE PATIENT. THE SHOCK IMPEDANCE AT IMPLANT WAS 55 OHMS AND OVER THE PAST YEAR HAD BEEN TRENDING IN THE LOW 100-125 OHM RANGE. THE PHYSICIAN WANTED TO CONFIRM WITH DELIVERED SHOCKS WHAT THE IMPEDANCE WAS. IMPEDANCES WITH A 1.1 JOULE SHOCK WERE 75 OHMS AND WITH A 31 JOULE SHOCK, THEY WERE 95 OHMS. THE PHYSICIAN WAS SATISFIED WITH THESE MEASUREMENTS. THE SHOCK LEAD IMPEDANCE TEST FOLLOWING SHOWED IMPEDANCES BETWEEN 108-111 OHMS. ALL LEAD VALUES WERE NOTED TO BE STABLE, BUT A BREAKDOWN OF THE VECTORS WERE NOTED TO BE HIGHER. THE DEVICE AND RV LEAD REMAIN IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) SHOCK LEAD IMPEDANCE MEASUREMENTS HAVE BEEN GRADUALLY INCREASING OVER THE LAST TWO YEARS. NOW, IMPEDANCES ARE AROUND 150 OHMS. THE LEAD HAS BEEN IMPLANTED FOR TEN YEARS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED CHECKING OTHER VECTORS AND PERFORMING A 1:1 JOULE SHOCK TO DETERMINE DELIVERED SHOCK IMPEDANCES AND THEN COMPARE THAT TO THE DAILY MEASUREMENTS AND MANUAL SHOCK IMPEDANCE TEST. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717484 ENDOTAK RELIANCE G IMPLANTABLE TRANSVENOUS CARDIOVERTER DEFIBRILLATOR LEAD LWS BOSTON SCIENTIFIC CORPORATION 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R