BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY MRI

    MDR report key: 12620266 · Received October 12, 2021

    Report

    Report Number
    2124215-2021-23943
    Event Type
    Injury
    Date Received
    October 12, 2021
    Date of Event
    July 19, 2021
    Report Date
    October 14, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    UDI-DI
    00802526523458
    PMA / PMN Number
    P150012/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING FILED DUE TO CORRECTION IN FIELDS B5 AND D4.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING WHICH RESULTED IN PACING INHIBITION. HOWEVER, THE PACING INHIBITION WAS LESS THAN TWO SECONDS. SUBSEQUENTLY, THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SUPPLEMENTAL REPORT IS BEING FILED AS ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATES THIS RIGHT ATRIAL (RA) LEAD WAS FRACTURED WHICH RESULTED IN NOISE THAT CAUSED THE PATIENT TO HAVE PACING INHIBITION AND SYNCOPE. ADDITIONALLY, IT WAS NOTED THAT PACING IMPEDANCES WERE HIGH WHEN PROGRAMMED IN BOTH UNIPOLAR AND BIPOLAR CONFIGURATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING WHICH RESULTED IN PACING INHIBITION. HOWEVER, THE PACING INHIBITION WAS LESS THAN TWO SECONDS. SUBSEQUENTLY, THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SUPPLEMENTAL REPORT IS BEING FILED AS ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATES THIS RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED WHICH RESULTED IN NOISE THAT CAUSED THE PATIENT TO HAVE PACING INHIBITION AND SYNCOPE. ADDITIONALLY, IT WAS NOTED THAT PACING IMPEDANCES WERE HIGH WHEN PROGRAMMED IN BOTH UNIPOLAR AND BIPOLAR CONFIGURATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING WHICH RESULTED IN PACING INHIBITION. HOWEVER, THE PACING INHIBITION WAS LESS THAN TWO SECONDS. SUBSEQUENTLY, THIS LEAD WAS SURGICALLY ABANDONED AND REPLACED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514885 INGEVITY MRI IMPLANTABLE LEAD NVN BOSTON SCIENTIFIC CORPORATION 7742 656609 00802526523458

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R