BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 17882488 · Received October 5, 2023

    Report

    Report Number
    2124215-2023-55233
    Event Type
    Malfunction
    Date Received
    October 5, 2023
    Date of Event
    September 2, 2023
    Report Date
    October 19, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P910073/S043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B5 AND CODE A072202 ADDED IN H6. CORRECTION: M/S, FIELD D4.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH SHOCK IMPEDANCES OUT OF RANGE. DURING THAT INITIAL REVIEW, AN INAPPROPRIATE SHOCK WAS FOUND DUE TO ATRIAL RHYTHM. THE BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) INDICATED THAT AFTER THE SHOCK ALL MEASUREMENTS HAVE RETURNED TO NORMAL. 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 SHOCK IMPEDANCES OUT OF RANGE AT 0 OHMS. DURING THAT INITIAL REVIEW, AN INAPPROPRIATE SHOCK WAS FOUND DUE TO CONDUCTED ATRIAL RHYTHM. THE BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) EXPLAINED THAT THIS UNEXPECTEDLY MEASUREMENTS AT ZERO CAN OCCUR DURING ELECTROMAGNETIC INTERFERENCE (EMI), ESPECIALLY DURING AN ABLATION. THE FIELD REPRESENTATIVE WILL INQUIRE WITH HEALTH CARE PROFESSIONAL (HCP) IF THIS WAS OCCURRING OR WHAT WAS PATIENT WAS DOING. AT THIS TIME, ALL MEASUREMENTS HAVE RETURNED TO NORMAL. 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 HIGH SHOCK IMPEDANCES OUT OF RANGE. DURING THAT INITIAL REVIEW, AN INAPPROPRIATE SHOCK WAS FOUND DUE TO ATRIAL RHYTHM. THE BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) INDICATED THAT AFTER THE SHOCK ALL MEASUREMENTS HAVE RETURNED TO NORMAL. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2037715 ENDOTAK RELIANCE G IMPLANTABLE LEAD LWS BOSTON SCIENTIFIC CORPORATION 0185 225740

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male