BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNAGEN EL ICD VR

    MDR report key: 9982025 · Received April 21, 2020

    Report

    Report Number
    2124215-2020-08782
    Event Type
    Malfunction
    Date Received
    April 21, 2020
    Date of Event
    January 20, 2020
    Report Date
    November 20, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526534287
    PMA / PMN Number
    P960040/S306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    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. THE RETURNED DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY. VISUAL EXAMINATION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING IMPLANT THERE WAS AN EXTRA SIGNAL NOTED OCCURRING EVERY 6 TO 12 SECONDS ON THE RIGHT VENTRICULAR (RV) CHANNEL. ALL LEAD MEASUREMENTS WERE WITHIN NORMAL LIMITS. AFTER A FEW HOURS THE SIGNAL HAD COMPLETELY DISAPPEARED AND POCKET MANIPULATION HAD NO AFFECT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED THAT IT WAS LIKELY AIR SINCE THE EXTRA SIGNAL WAS ONLY SEEN ON THE PACE SENSE CHANNEL. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS EXPLANTED OVER THREE AND A HALF YEARS LATER FOR THERAPY UPGRADE TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE. THE EXPLANT IS NOT RELATED TO THIS ISSUE AND THERE WERE NO FURTHER DOCUMENTED ISSUES. THE DEVICE WAS RETURNED FOR ANALYSIS TESTING.

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING IMPLANT THERE WAS AN EXTRA SIGNAL NOTED OCCURRING EVERY 6 TO 12 SECONDS ON THE RIGHT VENTRICULAR (RV) CHANNEL. ALL LEAD MEASUREMENTS WERE WITHIN NORMAL LIMITS. AFTER A FEW HOURS THE SIGNAL HAD COMPLETELY DISAPPEARED AND POCKET MANIPULATION HAD NO AFFECT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND DISCUSSED THAT IT WAS LIKELY AIR SINCE THE EXTRA SIGNAL WAS ONLY SEEN ON THE PACE SENSE CHANNEL. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446756 DYNAGEN EL ICD VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION D150 235307 00802526534287

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male