BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE MRI DR

    MDR report key: 14502887 · Received May 26, 2022

    Report

    Report Number
    2124215-2022-17912
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    May 2, 2022
    Report Date
    July 27, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526559228
    PMA / PMN Number
    P150012/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE REMAINS IMPLANTED; THEREFORE, TECHNICAL ANALYSIS CANNOT BE CONDUCTED. WITHOUT A RETURNED DEVICE IT IS NOT POSSIBLE TO DEFINITIVELY CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED OVERSENSING BY THE MINUTE VENTILATION (MV) SENSOR RESULTING IN RHYTHM ACCELERATION. THE RHYTHM WAS SUCCESSFULLY CONVERTED WITH DEACTIVATION OF THE MDV SENSOR, AND DEVICE DATA WAS SENT TO TECHNICAL SERVICES (TS) FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PACEMAKER EXHIBITED OVERSENSING BY THE MINUTE VENTILATION (MV) SENSOR RESULTING IN RHYTHM ACCELERATION. THE RHYTHM WAS SUCCESSFULLY CONVERTED WITH DEACTIVATION OF THE MDV SENSOR, AND DEVICE DATA WAS SENT TO TECHNICAL SERVICES (TS) FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. TECHNICAL SERVICES (TS) NOTED THE MEDIAN AND MAX RESPIRATORY RATE INCREASED SINCE MARCH 2022, POTENTIALLY POINTING TOWARDS A CHANGE IN BREATHING PATTERN THAT COULD IMPACT MV. BOTH IMPLANTED LEADS SHOW IN-RANGE AND STABLE LEAD MEASUREMENTS. TS ALSO RECOMMENDED THE HEALTH CARE PROFESSIONAL (HCP) CONFIRM THE DEVICE DOES NOT FEEL LOOSE IN THE POCKET. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. SHOULD ADDITIONAL FOLLOW-UP INFORMATION BE PROVIDED IN THE FUTURE, AN UPDATED REPORT WILL BE ISSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260252 ACCOLADE MRI DR IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION L311 304938 00802526559228

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other