BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 16244380 · Received January 25, 2023

    Report

    Report Number
    2124215-2023-03035
    Event Type
    Malfunction
    Date Received
    January 25, 2023
    Date of Event
    January 4, 2023
    Report Date
    April 18, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P910073/S041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE RELATED PULSE GENERATOR (G125/133209) RECEIVED AN ALERT THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING OUT OF RANGE (OOR) SHOCK IMPEDANCES. THE MOST RECENT RECORDED SHOCK IMPEDANCE MEASUREMENT IS 55 OHMS; HOWEVER, IT WAS SUSPECTED THAT THE MEASUREMENTS HAD RANGED FROM 40-70 OHMS OVER THE PAST YEAR. BOSTON SCIENTIFIC TECHNICAL SERVICES WERE CONSULTED, AND A TECHNICAL SERVICES REPRESENTATIVE RECOMMENDED FURTHER TROUBLE SHOOTING, (BRING PATIENT IN, EVALUATE IMPEDANCE VALUES IN EACH SHOCK VECTOR, PERFORM PATIENT MOVEMENTS, ISOMETRICS, AND POCKET MANIPULATION TO SEE IF NOISE OR JUMPS IN IMPEDANCES CAN BE PROVOKED, AND POSSIBLY DELIVER A 1.1 J AND 41 J SHOCK TO FIND TRUE IMPEDANCE MEASUREMENT). ADDITIONALLY, IT WAS RECOMMENDED TO HAVE THE PATIENT PERFORM A PATIENT-INITIATED INTERROGATION IN ORDER TO CHECK THE OOR VALUE VIA LATITUDE DATA (REMOTE MONITORING SYSTEM). THIS DEVICE CURRENTLY REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RELATED PULSE GENERATOR (G125/133209) RECEIVED AN ALERT THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING OUT OF RANGE (OOR) SHOCK IMPEDANCES. THE MOST RECENT RECORDED SHOCK IMPEDANCE MEASUREMENT IS 55 OHMS; HOWEVER, IT WAS SUSPECTED THAT THE MEASUREMENTS HAD RANGED FROM 40-70 OHMS OVER THE PAST YEAR. BOSTON SCIENTIFIC TECHNICAL SERVICES WERE CONSULTED, AND A TECHNICAL SERVICES CONSULTANT RECOMMENDED FURTHER TROUBLE SHOOTING (BRING PATIENT IN, EVALUATE IMPEDANCE VALUES IN EACH SHOCK VECTOR, PERFORM PATIENT MOVEMENTS, ISOMETRICS, AND POCKET MANIPULATION TO SEE IF NOISE OR JUMPS IN IMPEDANCES CAN BE PROVOKED, AND POSSIBLY DELIVER A 1.1 J AND 41 J SHOCK TO FIND TRUE IMPEDANCE MEASUREMENT). ADDITIONALLY, IT WAS RECOMMENDED TO HAVE THE PATIENT PERFORM A PATIENT-INITIATED INTERROGATION IN ORDER TO CHECK THE OOR VALUE VIA LATITUDE DATA (REMOTE MONITORING SYSTEM). THIS DEVICE CURRENTLY REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION: A GOOD FAITH EFFORT WAS SUBMITTED TO THE FIELD TO OBTAIN FURTHER INFORMATION AS TO WHETHER ANY FURTHER TROUBLE SHOOTING WAS PERFORMED, TO OBTAIN THE OUT-OF-RANGE IMPEDANCE VALUE, AND TO FIND OUT THE PLAN OF CARE INTENDED FOR THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059226 ENDOTAK RELIANCE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 0165

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male