BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 18833308 · Received March 4, 2024

    Report

    Report Number
    2124215-2024-13140
    Event Type
    Malfunction
    Date Received
    March 4, 2024
    Date of Event
    February 15, 2024
    Report Date
    June 24, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P910073/S043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 A REMOTE TRANSMISSION SHOWED AN ALERT FOR THE RIGHT VENTRICULAR (RV) SHOCK IMPEDANCES EXHIBITING HIGH, OUT OF RANGE MEASUREMENTS OF 151 OHMS. IT WAS NOTED THAT THE SHOCK LEAD TREND OBSERVED VARYING MEASUREMENTS FROM 120-147 OHMS OVER THE PAST YEAR. THERE IS NO NOISE SEEN ON THE PRESENTING OR STORED ELECTROGRAMS. THIS LEAD REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REMOTE TRANSMISSION SHOWED AN ALERT FOR THE RIGHT VENTRICULAR (RV) SHOCK IMPEDANCES EXHIBITING HIGH, OUT OF RANGE MEASUREMENTS OF 151 OHMS. IT WAS NOTED THAT THE SHOCK LEAD TREND OBSERVED VARYING MEASUREMENTS FROM 120-147 OHMS OVER THE PAST YEAR. THERE IS NO NOISE SEEN ON THE PRESENTING OR STORED ELECTROGRAMS. THIS LEAD REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION: A REQUEST FOR FURTHER DETAILS ABOUT THIS EVENT WAS MADE TO THE FIELD. THE FEEDBACK INDICATED THAT THE CURRENT DEVICE PARAMETERS ARE SATISFACTORY, AND AS SUCH, NO ADDITIONAL ACTION WILL BE REQUIRED. THE PATIENT IS SCHEDULED TO CONTINUE WITH ROUTINE FOLLOW-UP VISITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165423 ENDOTAK RELIANCE G IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 0184 314349

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown