BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAROSTIM NEO

    MDR report key: 14305630 · Received May 6, 2022

    Report

    Report Number
    3007972010-2022-00005
    Event Type
    Injury
    Date Received
    May 6, 2022
    Date of Event
    April 8, 2022
    Report Date
    May 5, 2022
    Manufacturer
    CVRX, INC.
    Product Code
    DSR
    PMA / PMN Number
    P180050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYSIS RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE REPORTED DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE EVENT WAS DETERMINED TO BE A LEAD BREAK NEAR THE PRIOR REPAIR. THE CAUSE OF THE BREAK WAS UNABLE TO BE DETERMINED. IT SHOULD BE NOTED THAT THE IDENTIFIED EXPECTED LIFE OF THE LEAD IS 10 YEARS AND THIS WAS IMPLANTED LONGER THAN THAT TIME WITH A PRIOR REPAIR OF THE LEAD DURING THE CLINICAL STUDY. THE DEVICE HISTORY RECORD FOR THIS DEVICE SERIAL NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE MET MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. CVRX ID# (B)(4).

    Description of Event or Problem · 0

    DURING A FOLLOW-UP IN MID 2021, THE LEAD IMPEDANCE ON THE RIGHT LEAD WAS GREATER THAN 3000 OHMS. A POSSIBLE RIGHT LEAD DEFECT WAS SUSPECTED BUT WAS UNABLE TO BE CONFIRMED AS THE SITE DECLINED TO PERFORM X-RAYS DUE TO PATIENT SENSITIVITY. THERAPY WAS SWITCHED TO THE LEFT LEAD AND THE SITE WANTED TO EXPLORE A LEAD REPAIR AT THE NEXT NORMAL BATTERY REPLACEMENT PROCEDURE. IT WAS NOTED THAT BOTH THE RIGHT AND LEFT LEADS HAD PREVIOUSLY BEEN REPAIRED DURING THE CLINICAL TRIAL WHICH WOULD COMPLICATE A SECOND LEAD REPAIR. ON (B)(6) 2022, A PROCEDURE WAS PERFORMED TO REPLACE THE IPG DUE TO NORMAL BATTERY DEPLETION AND REPAIR THE LEAD. THE LEAD WAS CUT ABOVE THE PREVIOUS REPAIR SECTION, AND THE IMPEDANCE MEASURED NORMAL. AFTER SEVERAL ATTEMPTS, THE LEAD WAS SUCCESSFULLY REPAIRED, AND THE SURGERY WAS LONGER THAN TYPICAL DUE TO THE CHALLENGING REPAIR. IT WAS UNKNOWN WHY THE LEAD HAD FRACTURED NEAR THE REPAIR. THERAPY REMAINED ACTIVE WITH NORMAL IMPEDANCE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236094 BAROSTIM NEO CAROTID SINUS LEAD DSR CVRX, INC. 1014R

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Required Intervention