BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE DR

    MDR report key: 15691731 · Received October 28, 2022

    Report

    Report Number
    2124215-2022-44161
    Event Type
    Injury
    Date Received
    October 28, 2022
    Date of Event
    September 1, 2022
    Report Date
    December 5, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526559174
    PMA / PMN Number
    N970003/S167
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. DIMENSIONAL ANALYSIS OF THE HEADER WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE 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. CORRECTION TO AWARE DATE

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED TO GET REVIEW OF HEART CONNECT DATA. TECHNICAL SERVICES REVIEWED AND THIS PACEMAKER EXHIBITED OCCASIONAL ATRIAL UNDERSENSING OF P-WAVES. THE DEVICE WAS RE-PROGRAMMED TO UNIPOLAR AND THERE WAS NO SENSING OF P-WAVES HOWEVER, THERE WAS A LOT OF NOISE. THE HCP DIDN'T WANT TO ADJUST THE SENSITIVITY HIGHER DUE TO OVERSENSING IN UNIPOLAR. THE DEVICE WAS PROGRAMMED TO VVIR UNTIL THEY CAN FURTHER REVIEW. SUBSEQUENTLY, THIS DEVICE AND NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD WAS EXPLANTED AND REPLACED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED TO GET REVIEW OF HEART CONNECT DATA. TECHNICAL SERVICES REVIEWED AND THIS PACEMAKER EXHIBITED OCCASIONAL ATRIAL UNDERSENSING OF P-WAVES. THE DEVICE WAS RE-PROGRAMMED TO UNIPOLAR AND THERE WAS NO SENSING OF P-WAVES HOWEVER, THERE WAS A LOT OF NOISE. THE HCP DIDN'T WANT TO ADJUST THE SENSITIVITY HIGHER DUE TO OVERSENSING IN UNIPOLAR. THE DEVICE WAS PROGRAMMED TO VVIR UNTIL THEY CAN FURTHER REVIEW. SUBSEQUENTLY, THIS DEVICE AND NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD WAS EXPLANTED AND REPLACED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED TO GET REVIEW OF HEART CONNECT DATA. TECHNICAL SERVICES REVIEWED AND THIS PACEMAKER EXHIBITED OCCASIONAL ATRIAL UNDERSENSING OF P-WAVES. THE DEVICE WAS RE-PROGRAMMED TO UNIPOLAR AND THERE WAS NO SENSING OF P-WAVES HOWEVER, THERE WAS A LOT OF NOISE. THE HCP DIDN'T WANT TO ADJUST THE SENSITIVITY HIGHER DUE TO OVERSENSING IN UNIPOLAR. THE DEVICE WAS PROGRAMMED TO VVIR UNTIL THEY CAN FURTHER REVIEW. SUBSEQUENTLY, THIS DEVICE AND NON-BOSTON SCIENTIFIC RIGHT ATRIAL (RA) LEAD WAS EXPLANTED AND REPLACED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2796984 ACCOLADE DR IMPLANTABLE DEVICE LWP BOSTON SCIENTIFIC CORPORATION L301 710503 00802526559174

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention| H