BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOMENTUM EL ICD DR

    MDR report key: 15571356 · Received October 10, 2022

    Report

    Report Number
    2124215-2022-40555
    Event Type
    Injury
    Date Received
    October 10, 2022
    Date of Event
    July 24, 2022
    Report Date
    October 10, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P960040/S385
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVIEW OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DATA WAS REQUESTED TO TECHNICAL SERVICES (TS) AS REPORTEDLY, THE NURSE WAS OBSERVING THE PATIENT AND DESCRIBED THEM AS LIFELESS FOR A PERIOD OF TIME. THERE IS SOME UNDERSENSING OF THE VENTRICULAR FIBRILLATION (VF) OBSERVED AND PROGRAMMING SUGGESTIONS WERE REQUESTED TO TS. UPON REVIEW OF THE DEVICE DATA BY TS, IT WAS DISCUSSED THAT THERE IS SOME UNDERSENSING DUE TO CROSS CHAMBER BLANKING AFTER AN ATRIAL PACE AND THE RHYTHM DEGRADES TO WHAT APPEARS TO BE POLYMORPHIC VF. THE PATIENT HAD TO BE RESCUED BY AN EXTERNAL DEFIBRILLATOR. PROGRAMMING RECOMMENDATIONS WERE PROVIDED BY TS. THE ICD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276625 MOMENTUM EL ICD DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION D121 223152

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other