BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALITUDE CRT-P

    MDR report key: 16847765 · Received May 1, 2023

    Report

    Report Number
    2124215-2023-20886
    Event Type
    Malfunction
    Date Received
    May 1, 2023
    Date of Event
    January 29, 2021
    Report Date
    May 1, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NKE
    UDI-DI
    00802526559389
    PMA / PMN Number
    P030005/S113
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM EXHIBITED AN INCREASE IN RIGHT VENTRICULAR (RV) PACING IMPEDANCE MEASUREMENTS, MEASURING FROM AROUND 800-900 OHMS AND NOW ARE AS HIGH AS 1,252 OHMS. TECHNICAL SERVICES DISCUSSED POSSIBLE CAUSES AND PROVIDED TROUBLESHOOTING OPTIONS. ADDITIONALLY, TS REVIEWED DEVICE DATA AND THERE WERE NO EPISODES OF NOISE HOWEVER, THERE WAS A STORED SAM EPISODE WHICH APPEARS TO BE DUE FROM A PROCEDURE THAT DAY. AT THIS TIME, THE DEVICE AND NON-BOSTON SCIENTIFIC RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711659 VALITUDE CRT-P IMPLANTABLE DEVICE NKE BOSTON SCIENTIFIC CORPORATION U125 711318 00802526559389

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male