BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMBLEM S-ICD ELECTRODE

    MDR report key: 16908563 · Received May 10, 2023

    Report

    Report Number
    2124215-2023-23203
    Event Type
    Injury
    Date Received
    May 10, 2023
    Date of Event
    April 25, 2023
    Report Date
    October 21, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P110042/S077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED ELECTRODE WAS THOROUGHLY INSPECTED AND ANALYZED. RESISTANCE TESTS WERE COMPLETED TO ASSESS ELECTRICAL PERFORMANCE AND INNER INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY AND ELECTRODE BODY FOUND NO ANOMALIES. LABORATORY ANALYSIS DID NOT IDENTIFY ANY ELECTRODE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A REMOTE DEVICE DATA REVIEW, TWO EPISODES OF OVER-SENSED NON-PHYSIOLOGICAL NOISE WERE NOTED FROM THIS SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM. THE EPISODES WERE UNTREATED AND DID NOT LEAD TO INAPPROPRIATE THERAPY. TECHNICAL SERVICES WAS CONTACTED AND PROVIDED THOROUGH IN-CLINIC TROUBLESHOOTING MEASURES TO ASSESS THE SYSTEM INTEGRITY. DIAGNOSTIC IMAGING WAS PERFORMED WHICH SHOWED A POTENTIAL FRACTURE NEAR THE SENSE A NODE OF THE S-ICD ELECTRODE. THE PHYSICIAN SCHEDULED AN ELECTRODE REVISION PROCEDURE, BUT THIS HAS NOT YET OCCURRED. AT THIS TIME, THE ELECTRODE REMAINS IMPLANTED AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A REMOTE DEVICE DATA REVIEW, TWO EPISODES OF OVER-SENSED NON-PHYSIOLOGICAL NOISE WERE NOTED FROM THIS SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM. THE EPISODES WERE UNTREATED AND DID NOT LEAD TO INAPPROPRIATE THERAPY. TECHNICAL SERVICES WAS CONTACTED AND PROVIDED THOROUGH IN-CLINIC TROUBLESHOOTING MEASURES TO ASSESS THE SYSTEM INTEGRITY. DIAGNOSTIC IMAGING WAS PERFORMED WHICH SHOWED A POTENTIAL FRACTURE NEAR THE SENSE A NODE OF THE S-ICD ELECTRODE. THE PHYSICIAN ELECTED TO SURGICALLY EXPLANT AND REPLACE THE ENTIRE S-ICD SYSTEM TO RESOLVE THE EVENT AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED S-ICD SYSTEM IS EXPECTED TO BE RETURNED FOR ANALYSIS, BUT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A REMOTE DEVICE DATA REVIEW, TWO EPISODES OF OVER-SENSED NON-PHYSIOLOGICAL NOISE WERE NOTED FROM THIS SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM. THE EPISODES WERE UNTREATED AND DID NOT LEAD TO INAPPROPRIATE THERAPY. TECHNICAL SERVICES WAS CONTACTED AND PROVIDED THOROUGH IN-CLINIC TROUBLESHOOTING MEASURES TO ASSESS THE SYSTEM INTEGRITY. DIAGNOSTIC IMAGING WAS PERFORMED WHICH SHOWED A POTENTIAL FRACTURE NEAR THE SENSE A NODE OF THE S-ICD ELECTRODE. THE PHYSICIAN SCHEDULED AN ELECTRODE REVISION PROCEDURE, BUT THIS HAS NOT YET OCCURRED. AT THIS TIME, THE ELECTRODE REMAINS IMPLANTED AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A REMOTE DEVICE DATA REVIEW, TWO EPISODES OF OVER-SENSED NON-PHYSIOLOGICAL NOISE WERE NOTED FROM THIS SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM. THE EPISODES WERE UNTREATED AND DID NOT LEAD TO INAPPROPRIATE THERAPY. TECHNICAL SERVICES WAS CONTACTED AND PROVIDED THOROUGH IN-CLINIC TROUBLESHOOTING MEASURES TO ASSESS THE SYSTEM INTEGRITY. DIAGNOSTIC IMAGING WAS PERFORMED WHICH SHOWED A POTENTIAL FRACTURE NEAR THE SENSE A NODE OF THE S-ICD ELECTRODE. THE PHYSICIAN ELECTED TO SURGICALLY EXPLANT AND REPLACE THE ENTIRE S-ICD SYSTEM TO RESOLVE THE EVENT AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE EXPLANTED S-ICD SYSTEM HAS BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198892 EMBLEM S-ICD ELECTRODE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 3501 120105

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Unknown Required Intervention| H