BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE SG

    MDR report key: 17991997 · Received October 23, 2023

    Report

    Report Number
    2124215-2023-58890
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    July 1, 2023
    Report Date
    February 21, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P910073/S043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    IF PERTINENT INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED GRADUALLY INCREASING SHOCK IMPEDANCE MEASUREMENTS REACHING 150-155 OHMS FOR THE PAST FEW MONTHS. IT WAS NOTED THAT THE SHOCK IMPEDANCE MEASUREMENT AT IMPLANT WAS 64 OHMS. TECHNICAL SERVICES (TS) REVIEWED TROUBLESHOOTING OPTIONS AND POSSIBLE CAUSES. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT EXHIBITED ANOTHER HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT OF 125 OHMS, WITH OTHER SHOCK IMPEDANC MEASUREMENTS AVERAGING IN THE 110-115 OHMS RANGE. TECHNICAL SERVICES (TS) REVIEWED TROUBLESHOOTING OPTIONS AND PROGRAMMING CONSIDERATIONS. THIS RV 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 GRADUALLY INCREASING SHOCK IMPEDANCE MEASUREMENTS REACHING 150-155 OHMS FOR THE PAST FEW MONTHS. IT WAS NOTED THAT THE SHOCK IMPEDANCE MEASUREMENT AT IMPLANT WAS 64 OHMS. TECHNICAL SERVICES (TS) REVIEWED TROUBLESHOOTING OPTIONS AND POSSIBLE CAUSES. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1852082 ENDOTAK RELIANCE SG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 0180 302257

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male