BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE SG

    MDR report key: 12644288 · Received October 17, 2021

    Report

    Report Number
    2124215-2021-28632
    Event Type
    Injury
    Date Received
    October 17, 2021
    Date of Event
    September 4, 2021
    Report Date
    June 24, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVY
    UDI-DI
    00802526531255
    PMA / PMN Number
    P910073/S077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) SHOCK IMPEDANCES MEASURING125 OHMS. TECHNICAL SERVICES (TS) BELIEVES IT COULD BE DUE TO A PHYSIOLOGIC CHANGE DUE TO THE GRADUAL RISE. TS RECOMMENDED TO INCREASE THE ALERT TO 150 OHMS AND COULD CONSIDER A MAX ENERGY SHOCK WHEN IMPEDANCES MEASURE 145 OHMS. AT THIS TIME, THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SUPPLEMENTAL REPORT IS BEING FILED AS ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED RIGHT VENTRICULAR (RV) PACING LEAD IMPEDANCES (PLI) ARE HIGH OUT-OF-RANGE (OOR). TECHNICAL SERVICES (TS) REVIEWED EVENTS AND FOUND HIGH RATE-EVENTS WITH ELECTROGRAM (EGM)S SHOWING NOISE. THE PATIENT WAS EVALUATED IN THE CLINIC AND THE NOISE COULD NOT BE RE-PRODUCED. ADDITIONALLY, THRESHOLDS COULD NOT BE CHECKED DUE TO THE NOISE. SHOCK LEAD IMPEDANCES WERE NOTED TO BE HIGH OOR MEASURING GREATER THAN 200 OHMS. PLI STARTED CLIMBING AROUND THE SAME TIME MEASURING FROM 400-2400 OHMS. REVIEW OF THE MOST RECENT VENTRICULAR EVENT THERE WAS NEARLY A FLAT LINE ON THE SHOCK CHANNEL UNTIL ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED. IT WAS SUSPECTED THE LEAD IS FRACTURED. TS RECOMMENDED TO PROGRAM THERAPY OFF UNTIL THE LEAD CAN BE REVISED. AT THIS TIME, THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) SHOCK IMPEDANCES MEASURING125 OHMS. TECHNICAL SERVICES (TS) BELIEVES IT COULD BE DUE TO A PHYSIOLOGIC CHANGE DUE TO THE GRADUAL RISE. TS RECOMMENDED TO INCREASE THE ALERT TO 150 OHMS AND COULD CONSIDER A MAX ENERGY SHOCK WHEN IMPEDANCES MEASURE 145 OHMS. AT THIS TIME, THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SUPPLEMENTAL REPORT IS BEING FILED AS ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED RIGHT VENTRICULAR (RV) PACING LEAD IMPEDANCES (PLI) ARE HIGH OUT-OF-RANGE (OOR). TECHNICAL SERVICES (TS) REVIEWED EVENTS AND FOUND HIGH RATE-EVENTS WITH ELECTROGRAM (EGM)S SHOWING NOISE. THE PATIENT WAS EVALUATED IN THE CLINIC AND THE NOISE COULD NOT BE RE-PRODUCED. ADDITIONALLY, THRESHOLDS COULD NOT BE CHECKED DUE TO THE NOISE. SHOCK LEAD IMPEDANCES WERE NOTED TO BE HIGH OOR MEASURING GREATER THAN 200 OHMS. PLI STARTED CLIMBING AROUND THE SAME TIME MEASURING FROM 400-2400 OHMS. REVIEW OF THE MOST RECENT VENTRICULAR EVENT THERE WAS NEARLY A FLAT LINE ON THE SHOCK CHANNEL UNTIL ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED. IT WAS SUSPECTED THE LEAD IS FRACTURED. TS RECOMMENDED TO PROGRAM THERAPY OFF UNTIL THE LEAD CAN BE REVISED. AT THIS TIME, THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SUPPLEMENTAL REPORT IS BEING FILED AS ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AND REPLACED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) SHOCK IMPEDANCES MEASURING125 OHMS. TECHNICAL SERVICES (TS) BELIEVES IT COULD BE DUE TO A PHYSIOLOGIC CHANGE DUE TO THE GRADUAL RISE. TS RECOMMENDED TO INCREASE THE ALERT TO 150 OHMS AND COULD CONSIDER A MAX ENERGY SHOCK WHEN IMPEDANCES MEASURE 145 OHMS. AT THIS TIME, THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SUPPLEMENTAL REPORT IS BEING FILED AS ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED RIGHT VENTRICULAR (RV) PACING LEAD IMPEDANCES (PLI) ARE HIGH OUT-OF-RANGE (OOR). TECHNICAL SERVICES (TS) REVIEWED EVENTS AND FOUND HIGH RATE-EVENTS WITH ELECTROGRAM (EGM)S SHOWING NOISE. THE PATIENT WAS EVALUATED IN THE CLINIC AND THE NOISE COULD NOT BE RE-PRODUCED. ADDITIONALLY, THRESHOLDS COULD NOT BE CHECKED DUE TO THE NOISE. SHOCK LEAD IMPEDANCES WERE NOTED TO BE HIGH OOR MEASURING GREATER THAN 200 OHMS. PLI STARTED CLIMBING AROUND THE SAME TIME MEASURING FROM 400-2400 OHMS. REVIEW OF THE MOST RECENT VENTRICULAR EVENT THERE WAS NEARLY A FLAT LINE ON THE SHOCK CHANNEL UNTIL ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED. IT WAS SUSPECTED THE LEAD IS FRACTURED. TS RECOMMENDED TO PROGRAM THERAPY OFF UNTIL THE LEAD CAN BE REVISED. AT THIS TIME, THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SUPPLEMENTAL REPORT IS BEING FILED AS ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AND REPLACED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THIS RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) SHOCK IMPEDANCES MEASURING 125 OHMS. TECHNICAL SERVICES (TS) BELIEVES IT COULD BE DUE TO A PHYSIOLOGIC CHANGE DUE TO THE GRADUAL RISE. TS RECOMMENDED TO INCREASE THE ALERT TO 150 OHMS AND COULD CONSIDER A MAX ENERGY SHOCK WHEN IMPEDANCES MEASURE 145 OHMS. AT THIS TIME, THE RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1542241 ENDOTAK RELIANCE SG IMPLANTABLE LEAD NVY BOSTON SCIENTIFIC CORPORATION 0293 422029 00802526531255

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention| H