BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNAGEN EL ICD DR

    MDR report key: 11767467 · Received May 3, 2021

    Report

    Report Number
    2124215-2021-11376
    Event Type
    Injury
    Date Received
    May 3, 2021
    Date of Event
    March 29, 2021
    Report Date
    May 3, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526534324
    PMA / PMN Number
    P960040/S306
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INDUCED VENTRICULAR TACHYCARDIA (VT) DUE TO PACING ON THE T-WAVE. IT WAS NOTED A PREMATURE VENTRICULAR CONTRACTION (PVC) WAS BLANKED DUE TO ATRIAL PACING AND THE PVC FALLING INTO THE NOISE REJECTION WINDOW. THE VT WAS SUCCESSFULLY CONVERTED WITH ONE MAXIMUM ENERGY SHOCK. TECHNICAL SERVICES DISCUSSED DECREASING THE RIGHT VENTRICULAR BLANKING PERIOD AFTER AN ATRIAL PACE TO MITIGATE PVC BLANKING. REPROGRAMMING THE LOWER RATE LIMIT WAS ALSO DISCUSSED TO ALLOW FOR LONGER VENTRICULAR-ATRIAL TIMING. THE DEVICE WAS SUBSEQUENTLY REPROGRAMMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655279 DYNAGEN EL ICD DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION D152 576065 00802526534324

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening