BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 7195022 · Received January 16, 2018

    Report

    Report Number
    2124215-2017-22651
    Event Type
    Injury
    Date Received
    January 16, 2018
    Date of Event
    November 21, 2017
    Report Date
    March 24, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526373732
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: WITH THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC DETERMINED THAT THIS LEAD EXHIBITED A GRADUAL RISE IN LOW-VOLTAGE SHOCK IMPEDANCE MEASUREMENTS (LVSI). THIS OBSERVATION MAY BE CONSISTENT WITH CALCIFICATION OF THE DEFIBRILLATION COIL(S), HOWEVER CAN ONLY BE CONFIRMED IF THE LEAD IS RETURNED FOR ANALYSIS. THE CALCIFICATION PHENOMENON MAY HAVE CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THE REVIEW OF THE DHR IDENTIFIED THAT THERE WERE NO PROCESS RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING THE PRODUCTION THAT COULD EXPLAIN THE EVENT. THE REVIEWS ENSURE EACH DEVICE MEETS SPECIFICATION PRIOR TO RELEASE FOR USE. THERE IS NO INDICATION THE DEVICE MANUFACTURING PROCESS CONTRIBUTED TO THE REPORTED COMPLAINT. DEVICE TECHNICAL ANALYSIS: THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC AND PHYSICAL ANALYSIS COULD NOT BE CONDUCTED. INVESTIGATION OF THE AVAILABLE INFORMATION/DATA DETERMINED THAT THE OBSERVED GRADUAL RISE IN LVSI MEASUREMENTS WAS LIKELY ASSOCIATED WITH CALCIFICATION, AS THERE WAS NO CONCLUSIVE EVIDENCE OF COMPROMISED PHYSICAL OR ELECTRICAL INTEGRITY OF THE LEAD. THIS CONDITION MAY DEVELOP OVER TIME AND CAN BE REFLECTED IN A GRADUAL AND SUSTAINED INCREASE IN SHOCK IMPEDANCE MEASUREMENTS. BOSTON SCIENTIFIC ISSUED A FIELD SAFETY NOTICE TO PHYSICIANS IN JULY 2025 REGARDING THE POTENTIAL FOR RELIANCE DEFIBRILLATION LEADS WITH EXPANDED POLYTETRAFLUOROETHYLENE (EPTFE) COATING TO EXHIBIT A PATTERN OF GRADUALLY INCREASING LVSI MEASUREMENTS DUE TO CALCIFICATION, WHICH MAY RESULT IN ELEVATED HIGH VOLTAGE SHOCK IMPEDANCE (HVSI) MEASUREMENTS AND REDUCED SHOCK EFFICACY. DEVICE LABELING REVIEW: REVIEW OF LABELING DETERMINED THAT THE COMPLAINT SITUATION WAS LISTED IN THE MANUAL. THERE WAS NO INDICATION IN THE COMPLAINT THAT THE PRODUCT WAS NOT USED IN ACCORDANCE TO LABELING. THE MANUAL WAS UNLIKELY TO BE THE CAUSE OF THE REPORTED COMPLAINT; TRANSLATION, WORDING, OR GRAPHICS DOES NOT REQUIRE FURTHER REVIEW. INVESTIGATION CONCLUSION: CAUSE WAS TRACED TO DEVICE DESIGN. GRADUALLY INCREASING LVSI MEASUREMENTS FOR LEADS WITH EPTFE COATING ARE SUSPECTED TO BE THE RESULT OF ENCAPSULATION OF THE LEAD COIL(S) DUE TO CALCIFICATION. BOSTON SCIENTIFIC ISSUED A FIELD SAFETY NOTICE TO PHYSICIANS IN JULY 2025 REGARDING THE POTENTIAL FOR RELIANCE DEFIBRILLATION LEADS WITH EPTFE COATING TO EXHIBIT THIS PHENOMENON.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL INCREASE IN SHOCK IMPEDANCES. RECENTLY, THE VALUES BECAME OUT OF RANGE AT VALUES GREATER THAN 125 OHMS. AT THIS TIME, THE RV LEAD REMAINS IN SERVICE. THE ALERT LIMIT WAS INCREASED AND THE PATIENT IS BEING MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT, THIS RV LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    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

    ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED ANOTHER ALERT FOR HIGH OUT OF RANGE SHOCK IMPEDANCES WAS TRIGGERED. THE VALUES WERE GREATER THAN 150 OHMS. AT THIS TIME, THE PATIENT IS EXPECTED TO BE SEEN BY THEIR ELECTROPHYSIOLOGIST. A LEAD REVISION MAY OCCUR, BUT NO INTERVENTIONS HAVE BEEN PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL INCREASE IN SHOCK IMPEDANCES. RECENTLY, THE VALUES BECAME OUT OF RANGE AT VALUES GREATER THAN 125 OHMS. AT THIS TIME, THE RV LEAD REMAINS IN SERVICE. THE ALERT LIMIT WAS INCREASED AND THE PATIENT IS BEING MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30339 ENDOTAK RELIANCE G IMPLANTABLE LEAD LWS BOSTON SCIENTIFIC CORPORATION 0175 00802526373732

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Hospitalization| R 0175.| 4136.| 4543.| N161.| T177.