BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 3043123 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-03335
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 25, 2013
    Report Date
    July 21, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526531187
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AND LEAD REMAIN IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. 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.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    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 THAT NON-INVASIVE PROGRAMMED STIMULATION (NIPS) WAS PERFORMED DURING THE LAST CLINIC VISIT FOR LEAD EVALUATION. THE SHOCK IMPEDANCES WERE WITHIN NORMAL RANGE. THE DEVICE WAS LEFT WITH THE PREVIOUS PROGRAMMING. THERE WAS NO ROOT CAUSE FOUND FOR THE OUT OF RANGE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THE PATIENT UNDERWENT A REVISION PROCEDURE. THE DEVICE WAS EXPLANTED AND THE LEAD REMAINS IN SERVICE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WERE DETECTED THROUGH REMOTE MONITORING SYSTEM ON THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS BROUGHT IN FOLLOWING THE SECOND OUT OF RANGE MEASUREMENT FOR EVALUATION. MANUAL TESTS IN CLINIC WERE PERFORMED SHOWING THE OUT OF RANGE MEASUREMENTS WERE FOUND IN VARIOUS PROGRAMMING CONFIGURATIONS. THE MEASUREMENTS WERE NOTED TO BE A GRADUAL RISE SINCE IMPLANT. THE LOCAL FIELD REPRESENTATIVE DISCUSSED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) TO PERFORM COMMAND SHOCKS OF 1.1J AND MAX ENERGY TO GET IMPEDANCE OF DELIVERED ENERGY FOR A TRUE TEST OF THE SYSTEM. THERE WERE NO ADVERSE PATIENT EFFECTS. A REQUEST FOR STATUS OF THE LEAD WAS SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE RIGHT VENTRICULAR (RV) LEAD SHOCK IMPEDANCE MEASUREMENT STARTED TO BECOME HIGH AGAIN AND REACHED 132 OHMS. A REMOTE HOME MONITORING ALERT WAS RECEIVED. AT THIS TIME THE CLINIC WILL LIKELY CONTINUE TO MONITOR THE PATIENT THROUGH THE REMOTE HOME MONITORING SYSTEM. THE RV LEAD REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147553 ENDOTAK RELIANCE G IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 0184 00802526531187
    147588 ENDOTAK RELIANCE G IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 0184 00802526531187

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Life Threatening| H| R 0184.| 4086.| A155.| E110.| A155| 4086| E110