BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNAGEN? EL ICD DR

    MDR report key: 21927063 · Received April 29, 2025

    Report

    Report Number
    2124215-2025-27187
    Event Type
    Injury
    Date Received
    April 29, 2025
    Date of Event
    April 8, 2025
    Report Date
    April 28, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526534829
    PMA / PMN Number
    P960040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 DEVICE CODE A160102. THE DEVICE REMAINS IMPLANTED; 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 THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TACHYCARDIA THERAPY HAS BEEN TURNED OFF DUE TO THE PATIENT CONDITION AND MOVING TO HOSPICE CARE. THE PATIENT HAD A MAGNET TAPED OVER THE DEVICE AND STILL THE PATIENT RECEIVED INAPPROPRIATE SHOCKS FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TACHYCARDIA THERAPY HAS BEEN TURNED OFF DUE TO THE PATIENT CONDITION AND MOVING TO HOSPICE CARE. THE PATIENT HAD A MAGNET TAPED OVER THE DEVICE AND STILL THE PATIENT RECEIVED INAPPROPRIATE SHOCKS FOR ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. IT WAS NOTED THAT NO BEEP TONES WERE HEARD WHEN THE MAGNET WAS OVER THE DEVICE, SUGGESTING MAGNET PLACEMENT WAS NOT OPTIMAL. THIS ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181121 DYNAGEN? EL ICD DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION D153 221830 00802526534829

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Other