BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIGILANT EL ICD DR

    MDR report key: 20879123 · Received December 9, 2024

    Report

    Report Number
    2124215-2024-77561
    Event Type
    Malfunction
    Date Received
    December 9, 2024
    Date of Event
    November 22, 2024
    Report Date
    March 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P960040/S385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY. VISUAL EXAMINATION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. DIMENSIONAL ANALYSIS OF THE HEADER WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED, AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS AN ATTEMPT DURING IMPLANT PROCEDURE. THE PROCEDURE WAS A STANDARD DEVICE REPLACEMENT FOR ELECTIVE REPLACEMENT INDICATOR. ALL THE PARAMETERS BY THE PREVIOUS DEVICE WERE STABLE AND GOOD. ONCE THIS ICD WAS CONNECTED DURING POCKET CLOSURE, NOISE OVERSENSING WAS EXHIBITED ON THE RIGHT VENTRICULAR (RV) CHANNEL. AFTER SEVERAL TEST OF DEVICE CONNECTION AND LEAD THROUGH PACING SYSTEM ANALYZER THE NOISE WAS STILL REPRODUCIBLE ONLY BY THE DEVICE UNDER THE POCKET. THE PHYSICIAN, WITH THE FIELD REPRESENTATIVE AND TECHNICAL SERVICES (TS) DECIDED TO REPLACE THIS ICD. A NEW ICD WAS SUCCESSFULLY IMPLANTED WITH NO MORE NOISE OVERSENSING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS AN ATTEMPT DURING IMPLANT PROCEDURE. THE PROCEDURE WAS A STANDARD DEVICE REPLACEMENT FOR ELECTIVE REPLACEMENT INDICATOR. ALL THE PARAMETERS BY THE PREVIOUS DEVICE WERE STABLE AND GOOD. ONCE THIS ICD WAS CONNECTED DURING POCKET CLOSURE, NOISE OVERSENSING WAS EXHIBITED ON THE RIGHT VENTRICULAR (RV) CHANNEL. AFTER SEVERAL TEST OF DEVICE CONNECTION AND LEAD THROUGH PACING SYSTEM ANALYZER THE NOISE WAS STILL REPRODUCIBLE ONLY BY THE DEVICE UNDER THE POCKET. THE PHYSICIAN, WITH THE FIELD REPRESENTATIVE AND TECHNICAL SERVICES (TS) DECIDED TO REPLACE THIS ICD. A NEW ICD WAS SUCCESSFULLY IMPLANTED WITH NO MORE NOISE OVERSENSING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133692 VIGILANT EL ICD DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS BOSTON SCIENTIFIC CORPORATION D233 665166

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown