BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE LEAD

    MDR report key: 14162128 · Received April 20, 2022

    Report

    Report Number
    2124215-2022-10246
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 7, 2022
    Report Date
    May 22, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PHYSICIAN OBSERVED TWO EPISODES OF NOISE WITH OVERSENSING THAT LED TO PACING INHIBITION IN THIS PACEMAKER SYSTEM. THE PATIENT EXPERIENCED APPROXIMATELY THREE TO FOUR SECONDS OF ASYSTOLE. IT IS SUSPECTED BY THE CLINIC THAT THE NOISE IS POTENTIALLY CAUSED BY AN EXTERNAL SOURCE OF ELECTROMAGNETIC INTERFERENCE (EMI) AND TECHNICAL ANALYSIS WAS REQUESTED TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS). TROUBLESHOOTING WAS PERFORMED IN CLINIC, IN WHICH THE NOISE WAS UNABLE TO BE REPRODUCED AND THE DEVICE SENSITIVITY WAS INCREASED. EVALUATION OF THE DEVICE DATA BY TS INDICATES THAT A LEAD INTEGRITY COMPROMISE CANNOT BE EXCLUDED, AND THE RECOMMENDATION IS TO PERFORM THE TROUBLESHOOTING STEPS PROVIDED ENSURING THAT IT IS AS EXHAUSTIVE AS POSSIBLE. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD SHOWS HIGH VARIABILITY IN THE AMPLITUDE MEASUREMENTS THAT COULD BE POTENTIALLY RELATED TO NOISE AS SEEN ON THE VENTRICULAR EPISODES. IN ADDITION, THE RV THRESHOLD SEEMS TO BE HAVING A VERY GRADUAL INCREASE AND GIVEN THE CHARACTERISTICS OF THE RV NOISE IN THE AVAILABLE EPISODES, LEAD IMPAIRMENT CANNOT BE EXCLUDED. FURTHER TROUBLESHOOTING RECOMMENDATIONS WERE PROVIDED BY TS. THE RIGHT ATRIAL (RA) AND RV LEADS MODEL/SERIAL NUMBERS ARE NOT AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PHYSICIAN OBSERVED TWO EPISODES OF NOISE WITH OVERSENSING THAT LED TO PACING INHIBITION IN THIS PACEMAKER SYSTEM. THE PATIENT EXPERIENCED APPROXIMATELY THREE TO FOUR SECONDS OF ASYSTOLE. IT IS SUSPECTED BY THE CLINIC THAT THE NOISE IS POTENTIALLY CAUSED BY AN EXTERNAL SOURCE OF ELECTROMAGNETIC INTERFERENCE (EMI) AND TECHNICAL ANALYSIS WAS REQUESTED TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS). TROUBLESHOOTING WAS PERFORMED IN CLINIC, IN WHICH THE NOISE WAS UNABLE TO BE REPRODUCED AND THE DEVICE SENSITIVITY WAS INCREASED. EVALUATION OF THE DEVICE DATA BY TS INDICATES THAT A LEAD INTEGRITY COMPROMISE CANNOT BE EXCLUDED, AND THE RECOMMENDATION IS TO PERFORM THE TROUBLESHOOTING STEPS PROVIDED ENSURING THAT IT IS AS EXHAUSTIVE AS POSSIBLE. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD SHOWS HIGH VARIABILITY IN THE AMPLITUDE MEASUREMENTS THAT COULD BE POTENTIALLY RELATED TO NOISE AS SEEN ON THE VENTRICULAR EPISODES. IN ADDITION, THE RV THRESHOLD SEEMS TO BE HAVING A VERY GRADUAL INCREASE AND GIVEN THE CHARACTERISTICS OF THE RV NOISE IN THE AVAILABLE EPISODES, LEAD IMPAIRMENT CANNOT BE EXCLUDED. FURTHER TROUBLESHOOTING RECOMMENDATIONS WERE PROVIDED BY TS. THE RIGHT ATRIAL (RA) AND RV LEADS MODEL/SERIAL NUMBERS ARE NOT AVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS. ADDITIONAL INFORMATION PROVIDED INDICATES THAT THE TROUBLESHOOTING STEPS PERFORMED WERE UNABLE TO REPRODUCE ANY NOISE AND THE CAUSE OF THE NOISE OVERSENSING WAS NOT DETERMINED. THE PATIENT WILL CONTINUE TO BE MONITORED VIA LATITUDE. IN ADDITION, THE RA AND RV LEADS MODEL/SERIAL NUMBERS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409667 IMPLANTABLE LEAD LWS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown