BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY+

    MDR report key: 19102185 · Received April 12, 2024

    Report

    Report Number
    2124215-2024-22426
    Event Type
    Injury
    Date Received
    April 12, 2024
    Date of Event
    April 11, 2024
    Report Date
    July 9, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO UPDATE THE IMPACT CODES.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO UPDATE THE IMPLANT DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT PRESENTED TO THE CLINIC DUE TO A RIGHT ATRIAL (RA) LEAD REPOSITIONING PROCEDURE. IT WAS NOTED THAT THERE WAS NO P WAVE SENSING AND NO CAPTURE FROM THE PRE PROCEDURE CHECK, AND FLUOROSCOPY CONFIRMED THAT THE LEAD HAD DISLODGED FROM ITS ORIGINAL IMPLANT LOCATION. THE LEAD WAS SUCCESSFULLY REPOSITIONED TO THE LATERAL ATRIAL WALL AND ALL MEASUREMENTS WERE APPROPRIATE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT PRESENTED TO THE CLINIC DUE TO A RIGHT ATRIAL (RA) LEAD REPOSITIONING PROCEDURE. IT WAS NOTED THAT THERE WAS NO P WAVE SENSING AND NO CAPTURE FROM THE PRE PROCEDURE CHECK AND FLUOROSCOPY CONFIRMED THAT THE LEAD HAD DIALOGED FROM ITS ORIGINAL IMPLANT LOCATION. THE LEAD WAS SUCCESSFULLY REPOSITIONED TO THE LATERAL ATRIAL WALL AND ALL MEASUREMENTS WERE APPROPRIATE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT PRESENTED TO THE CLINIC DUE TO A RIGHT ATRIAL (RA) LEAD REPOSITIONING PROCEDURE. IT WAS NOTED THAT THERE WAS NO P WAVE SENSING AND NO CAPTURE FROM THE PRE PROCEDURE CHECK, AND FLUOROSCOPY CONFIRMED THAT THE LEAD HAD DISLODGED FROM ITS ORIGINAL IMPLANT LOCATION. THE LEAD WAS SUCCESSFULLY REPOSITIONED TO THE LATERAL ATRIAL WALL AND ALL MEASUREMENTS WERE APPROPRIATE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401006 INGEVITY+ DRUG ELUTING PERMANENT RIGHT VENTRICULAR OR ATRIAL PACEMAKER ELECTRODES NVN BOSTON SCIENTIFIC CORPORATION 7841 1371179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R