BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE MRI EL DR

    MDR report key: 10021384 · Received May 4, 2020

    Report

    Report Number
    2124215-2020-09687
    Event Type
    Malfunction
    Date Received
    May 4, 2020
    Date of Event
    March 22, 2020
    Report Date
    July 7, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    UDI-DI
    00802526559266
    PMA / PMN Number
    P150012/S000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, AND AS A RESULT, LABORATORY ANALYSIS COULD NOT BE CONDUCTED. INVESTIGATION OF THE AVAILABLE INFORMATION DETERMINED THIS DEVICE EXHIBITED OVERSENSING OF NOISE GENERATED BY THE MINUTE VENTILATION (MV)/RESPIRATORY SENSOR THAT IS RELATED TO A HIGH IMPEDANCE CONDITION. PLEASE SEE THE DESCRIPTION FOR MORE INFORMATION REGARDING THE SPECIFIC CIRCUMSTANCES OF THIS EVENT. THIS DEVICE WAS INCLUDED IN THE RECENT MINUTE VENTILATION SENSOR SIGNAL OVERSENSING ADVISORY POPULATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACEMAKER HAD A SIGNAL ARTIFACT MONITORING (SAM) EPISODE DUE TO OVERSENSING OF THE MINUTE VENTILATION SIGNAL. THE SAM EPISODE SWITCHED MONITORING FROM THE ATRIAL LEAD TO THE RIGHT VENTRICULAR (RV) LEAD. FURTHER REVIEW FOUND A STORED ATRIAL TACHY RESPONSE (ATR) EVENT DUE TO OVERSENSING OF NOISE. IT WAS NOTED THAT THE PATIENT IS 100 PERCENT PACED IN THE ATRIUM. THE MEDICAL PERSONNEL NOTED THAT TWO MONTHS EARLIER WHEN THE RIGHT ATRIAL AUTOMATIC THRESHOLD (RAAT WAS TURNED ON THEY WERE UNABLE TO VERIFY ATRIAL CAPTURE AND THE RV LEAD IMPEDANCE HAD BEEN GRADUALLY INCREASING, BUT WAS STILL WITHIN NORMAL LIMITS. SINCE THE PATIENT HAD RECENTLY BEEN TRAVELING THE CLINIC WAS RELUCTANT TO BRING HIM IN DUE TO COVID-19. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED PROGRAMMING CHANGE OPTIONS. THE FIELD REPRESENTATIVE FOLLOWED UP WITH THE CLINIC A FEW WEEKS LATER AND IT WAS STATED THAT NO CAUSE WAS DETERMINED AND THEY ARE CONTINUING TO MONITOR THE PATIENT REMOTELY. THE PACEMAKER, RIGHT ATRIAL (RA) AND RV LEADS REMAIN IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACEMAKER HAD A SIGNAL ARTIFACT MONITORING (SAM) EPISODE DUE TO OVERSENSING OF THE MINUTE VENTILATION SIGNAL. THE SAM EPISODE SWITCHED MONITORING FROM THE ATRIAL LEAD TO THE RIGHT VENTRICULAR (RV) LEAD. FURTHER REVIEW FOUND A STORED ATRIAL TACHY RESPONSE (ATR) EVENT DUE TO OVERSENSING OF NOISE. IT WAS NOTED THAT THE PATIENT IS 100 PERCENT PACED IN THE ATRIUM. THE MEDICAL PERSONNEL NOTED THAT TWO MONTHS EARLIER WHEN THE RIGHT ATRIAL AUTOMATIC THRESHOLD (RAAT WAS TURNED ON THEY WERE UNABLE TO VERIFY ATRIAL CAPTURE AND THE RV LEAD IMPEDANCE HAD BEEN GRADUALLY INCREASING, BUT WAS STILL WITHIN NORMAL LIMITS. SINCE THE PATIENT HAD RECENTLY BEEN TRAVELING THE CLINIC WAS RELUCTANT TO BRING HIM IN DUE TO COVID-19. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED PROGRAMMING CHANGE OPTIONS. THE FIELD REPRESENTATIVE FOLLOWED UP WITH THE CLINIC A FEW WEEKS LATER AND IT WAS STATED THAT NO CAUSE WAS DETERMINED AND THEY ARE CONTINUING TO MONITOR THE PATIENT REMOTELY. THE PACEMAKER, RIGHT ATRIAL (RA) AND RV LEADS REMAIN IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484143 ACCOLADE MRI EL DR IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION L331 857750 00802526559266

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR