BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY MRI

    MDR report key: 17904575 · Received October 10, 2023

    Report

    Report Number
    2124215-2023-55902
    Event Type
    Injury
    Date Received
    October 10, 2023
    Date of Event
    September 27, 2023
    Report Date
    December 19, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    UDI-DI
    00802526523427
    PMA / PMN Number
    P150012/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED CODE FOR UN-RETRIEVED DEVICE FRAGMENTS UPON REVIEW BY OUR MEDICAL TEAM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM HAD A STORED SIGNAL ARTIFACT MONITOR (SAM) EPISODE. TECHNICAL SERVICES (TS) EXAMINED DEVICE EPISODE DATA AND FOUND THAT THERE WAS OVERSENSING OF RESPIRATORY RATE TREND (RRT) NOISE WITH INHIBITION OF PACING FOR ONE BEAT ON THE RIGHT ATRIAL (RA) LEAD CHANNEL. THE PACING IMPEDANCE VALUES FOR THE RA LEAD WERE GREATER THAN 3000 OHMS, WHICH WAS OUT OF RANGE. THE PATIENT WAS TESTED IN CLINIC, INCLUDING ISOMETRICS AND MANIPULATIONS, AND IT WAS FOUND THAT THE SENSING ON THE RA LEAD WAS LOW AND INTERMITTENT WITH NO CAPTURE AT MAXIMUM OUTPUT. IT WAS NOTED THAT THE PLAN IS TO EXTRACT THE RA LEAD AT A LATER DATE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS ICD SYSTEM REMAINS IN SERVICE. ACCORDING TO ADDITIONAL INFORMATION, THIS LEAD WAS EXPLANTED DUE TO A FRACTURE AND SUBSEQUENTLY REPLACED WITH A NEW RA LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AS OF TODAY, THIS PRODUCT HAS NOT BEEN RECEIVED BY BOSTON SCIENTIFIC FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM HAD A STORED SIGNAL ARTIFACT MONITOR (SAM) EPISODE. TECHNICAL SERVICES (TS) EXAMINED DEVICE EPISODE DATA AND FOUND THAT THERE WAS OVERSENSING OF RESPIRATORY RATE TREND (RRT) NOISE WITH INHIBITION OF PACING FOR ONE BEAT ON THE RIGHT ATRIAL (RA) LEAD CHANNEL. THE PACING IMPEDANCE VALUES FOR THE RA LEAD WERE GREATER THAN 3000 OHMS, WHICH WAS OUT OF RANGE. THE PATIENT WAS TESTED IN CLINIC, INCLUDING ISOMETRICS AND MANIPULATIONS, AND IT WAS FOUND THAT THE SENSING ON THE RA LEAD WAS LOW AND INTERMITTENT WITH NO CAPTURE AT MAXIMUM OUTPUT. IT WAS NOTED THAT THE PLAN IS TO EXTRACT THE RA LEAD AT A LATER DATE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS ICD SYSTEM REMAINS IN SERVICE. ACCORDING TO ADDITIONAL INFORMATION, THIS LEAD WAS EXPLANTED AND REPLACED WITH A NEW RA LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AS OF TODAY, THIS PRODUCT HAS NOT BEEN RECEIVED BY BOSTON SCIENTIFIC FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM HAD A STORED SIGNAL ARTIFACT MONITOR (SAM) EPISODE. TECHNICAL SERVICES (TS) EXAMINED DEVICE EPISODE DATA AND FOUND THAT THERE WAS OVERSENSING OF RESPIRATORY RATE TREND (RRT) NOISE WITH INHIBITION OF PACING FOR ONE BEAT ON THE RIGHT ATRIAL (RA) LEAD CHANNEL. THE PACING IMPEDANCE VALUES FOR THE RA LEAD WERE GREATER THAN 3000 OHMS, WHICH WAS OUT OF RANGE. THE PATIENT WAS TESTED IN CLINIC, INCLUDING ISOMETRICS AND MANIPULATIONS, AND IT WAS FOUND THAT THE SENSING ON THE RA LEAD WAS LOW AND INTERMITTENT WITH NO CAPTURE AT MAXIMUM OUTPUT. IT WAS NOTED THAT THE PLAN IS TO EXTRACT THE RA LEAD AT A LATER DATE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS ICD SYSTEM REMAINS IN SERVICE. ACCORDING TO ADDITIONAL INFORMATION, THIS LEAD WAS EXPLANTED DUE TO A FRACTURE AND SUBSEQUENTLY REPLACED WITH A NEW RA LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. AS OF TODAY, THIS PRODUCT HAS NOT BEEN RECEIVED BY BOSTON SCIENTIFIC FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM HAD A STORED SIGNAL ARTIFACT MONITOR (SAM) EPISODE. TECHNICAL SERVICES (TS) EXAMINED DEVICE EPISODE DATA AND FOUND THAT THERE WAS OVERSENSING OF RESPIRATORY RATE TREND (RRT) NOISE WITH INHIBITION OF PACING FOR ONE BEAT ON THE RIGHT ATRIAL (RA) LEAD CHANNEL. THE PACING IMPEDANCE VALUES FOR THE RA LEAD WERE GREATER THAN 3000 OHMS, WHICH WAS OUT OF RANGE. THE PATIENT WAS TESTED IN CLINIC, INCLUDING ISOMETRICS AND MANIPULATIONS, AND IT WAS FOUND THAT THE SENSING ON THE RA LEAD WAS LOW AND INTERMITTENT WITH NO CAPTURE AT MAXIMUM OUTPUT. IT WAS NOTED THAT THE PLAN IS TO EXTRACT THE RA LEAD AT A LATER DATE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. CURRENTLY, THIS ICD SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335733 INGEVITY MRI IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7740 704506 00802526523427

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male Hospitalization| R