BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESONATE EL ICD VR

    MDR report key: 21763484 · Received April 3, 2025

    Report

    Report Number
    2124215-2025-20601
    Event Type
    Injury
    Date Received
    April 3, 2025
    Date of Event
    March 7, 2025
    Report Date
    April 8, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526588051
    PMA / PMN Number
    P960040/S385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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.

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS AMENDED TO UPDATE INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) CODES. INCOMPLETE CODING OF THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH CAPA-8580, WHICH FOCUSED ON IDENTIFYING AND REMEDIATING INCOMPLETE CODING OF EVENTS. ADDED PATIENT CODE E060110. THE DEVICE REMAINS IMPLANTED AND IN SERVICE; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE ALERTS FOR ANTI-TACHYCARDIA PACING (ATP) THERAPY AND VENTRICULAR SHOCK THERAPY DELIVERED TO CONVERT AN ARRHYTHMIA WERE GENERATED. ADDITIONALLY, ALERTS FOR AN ACCELERATED VENTRICULAR ARRHYTHMIA EPISODE WERE GENERATED AND ASSOCIATED WITH TWO OF THE THERAPY DELIVERY ALERTS. REVIEW OF BOTH EPISODES WITH THE ACCELERATED VENTRICULAR ARRHYTHMIA IDENTIFIED THE RHYTHM ACCELERATED FROM THE VENTRICULAR TACHYCARDIA (VT) ZONE TO THE VENTRICULAR FIBRILLATION (VF) ZONE POST-DELIVERY OF ATP THERAPY. OCCASIONAL UNDERSENSING OF FINE VF WAS NOTED. REDETECTION OCCURRED AND A 41J SHOCK SUCCESSFULLY CONVERTED THE RHYTHM IN BOTH TIMES. THE CLINICAL OBSERVATIONS WERE DOCUMENTED, AND THE SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE ALERTS FOR ANTI-TACHYCARDIA PACING (ATP) THERAPY AND VENTRICULAR SHOCK THERAPY DELIVERED TO CONVERT AN ARRHYTHMIA WERE GENERATED. ADDITIONALLY, ALERTS FOR AN ACCELERATED VENTRICULAR ARRHYTHMIA EPISODE WERE GENERATED AND ASSOCIATED WITH TWO OF THE THERAPY DELIVERY ALERTS. REVIEW OF BOTH EPISODES WITH THE ACCELERATED VENTRICULAR ARRHYTHMIA IDENTIFIED THE RHYTHM ACCELERATED FROM THE VENTRICULAR TACHYCARDIA (VT) ZONE TO THE VENTRICULAR FIBRILLATION (VF) ZONE POST-DELIVERY OF ATP THERAPY. OCCASIONAL UNDERSENSING OF FINE VF WAS NOTED. REDETECTION OCCURRED AND A 41J SHOCK SUCCESSFULLY CONVERTED THE RHYTHM IN BOTH EPISODES. THE CLINICAL OBSERVATIONS WERE DOCUMENTED, AND THE SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448927 RESONATE EL ICD VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION D432 327780 00802526588051

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Unknown Other