BEUDAMED
    FDA Adverse Event Other Summary report: N

    SERTROX S

    MDR report key: 17392825 · Received July 24, 2023

    Report

    Report Number
    MW5120039
    Event Type
    Other
    Date Received
    July 24, 2023
    Report Date
    May 26, 2023
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    NVN
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIAC RE-SYNCHRONIZATION 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(SYSTOLIC ANTERIOR MOTION) EPISODE WHICH APPEARS TO BE DUE FROM A PROCEDURE THAT DAY. AT THIS TIME, THE DEVICE AND THIS NON-(B)(6) RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1809656 SERTROX S DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACE NVN BIOTRONIK, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown