BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNAGEN MINI ICD VR

    MDR report key: 15228984 · Received August 15, 2022

    Report

    Report Number
    2124215-2022-30618
    Event Type
    Injury
    Date Received
    August 15, 2022
    Date of Event
    August 3, 2022
    Report Date
    August 15, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526533860
    PMA / PMN Number
    P960040/S306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT PASSED OUT, WENT TO THE EMERGENCY ROOM, AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT REPORTED THAT THE ELECTROCARDIOGRAM (ECG) IN THEIR HOSPITAL ROOM SHOWED A HEART RATE OF 84 BEATS PER MINUTE BUT DID NOT SHOW DEVICE PACING ACTIVITY FROM THEIR SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE. THE PATIENT ALSO NOTED THAT THEY NEVER RECEIVED A SHOCK FROM THEIR ICD DEVICE. THE PATIENT CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ASKING WHY THE ECG DID NOT SHOW DEVICE PACING ACTIVITY. TS DISCUSSED DEMAND PACING AND POSSIBLE PROGRAMMED LOWER RATE LIMIT (LRL). THE PATIENT INDICATED THEY DID NOT KNOW THEIR LRL PROGRAMMING. TS REFERRED THE PATIENT TO THEIR FOLLOWING PHYSICIAN FOR FURTHER DISCUSSION OF DEVICE OPERATION. ATTEMPTS TO GATHER ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE DEVICE REMAINS IN-SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287337 DYNAGEN MINI ICD VR IMPLANTABLE DEVICE LWS BOSTON SCIENTIFIC CORPORATION D020 210668 00802526533860

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Hospitalization