BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPONENT MRI DR

    MDR report key: 17886971 · Received October 6, 2023

    Report

    Report Number
    2124215-2023-55324
    Event Type
    Malfunction
    Date Received
    October 6, 2023
    Date of Event
    September 30, 2023
    Report Date
    October 26, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    PMA / PMN Number
    P150012/S000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT'S REMOTE COMMUNICATOR DISPLAYED A RED CALL DOCTOR ICON. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ASKED THE PATIENT TO PERFORM A PATIENT-INITIATED INTERROGATION (PII) AND AFTER TROUBLESHOOTING, A SUCCESSFUL PII WAS SENT. FURTHER INVESTIGATION FOUND THAT AN ALERT FOR RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE LOW OUT OF RANGE HAD BEEN STORED. THE PATIENT WAS REFERRED TO THE CLINIC FOR EVALUATION AND NO ADVERSE EFFECTS WERE REPORTED. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT'S REMOTE COMMUNICATOR DISPLAYED A RED CALL DOCTOR ICON. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ASKED THE PATIENT TO PERFORM A PATIENT-INITIATED INTERROGATION (PII) AND AFTER TROUBLESHOOTING, A SUCCESSFUL PII WAS SENT. FURTHER INVESTIGATION FOUND THAT AN ALERT FOR RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE LOW OUT OF RANGE HAD BEEN STORED. THE PATIENT WAS REFERRED TO THE CLINIC FOR EVALUATION AND NO ADVERSE EFFECTS WERE REPORTED. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. THE DEVICE REMAINS IN SERVICE. ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT WAS CHECKED, BUT LEAD REVISION WAS NOT PERFORMED PER PHYSICIANS DECISION. LOW PACING IMPEDANCE, HIGH PACING THRESHOLD MEASUREMENTS AND NOISY SIGNALS, ARE KNOWN RV LEAD OBSERVATIONS FOR THIS PATIENT. THE DEVICE WAS REPROGRAMMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT'S REMOTE COMMUNICATOR DISPLAYED A RED CALL DOCTOR ICON. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ASKED THE PATIENT TO PERFORM A PATIENT-INITIATED INTERROGATION (PII) AND AFTER TROUBLESHOOTING, A SUCCESSFUL PII WAS SENT. FURTHER INVESTIGATION FOUND THAT AN ALERT FOR RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE LOW OUT OF RANGE HAD BEEN STORED. THE PATIENT WAS REFERRED TO THE CLINIC FOR EVALUATION AND NO ADVERSE EFFECTS WERE REPORTED. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. THE DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219140 PROPONENT MRI DR PACEMAKER LWP BOSTON SCIENTIFIC CORPORATION L211 708505

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown