BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

    MDR report key: 17526179 · Received August 12, 2023

    Report

    Report Number
    MW5133119
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    September 8, 2020
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWS
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    Q: PT HAD AN ALERT FOR RVC IMPEDANCE 209 OHMS, BUT MAXIMUM VALUE FOR ALERT RANGE IS 200 OHMS. D: CLARIFY WITH CALLER THROUGH HER REVIEW OF QUICKLOOK THAT THE ALERT WAS FOR RVTRVC IMPEDANCE. RVT-RVR IMPEDANCE IS -300 OHMS IN LEAD TRENDS AND MOST RECENT RVT-RVC IMPDEANCE IS 209 OHMS. CALLER DOES HAVE FULL REPORT FROM INTERROGATION TO REVIEW ALERTS. CALLER HAD BROUGHT PT IN AND DONE TESTING INCLUDING WITH NO INDICATION OF A LEAD ISSUE. R: DISCUSSED DIFFERENCES BETWEEN RV DEFIB IMPEDANCE AND PACING IMPEDANCE. DISCUSSED ALERT PROGRAMMING. IF THE ALERT WAS FOR TTC IMPEDANCE, IT SOUNDS LIKE THIS ALERT MAY BE DUE TO NORMAL VARIATION IN PT WITH LOW INTRISIC IMPEDANCE. IF THE IMPEDANCE ALERT WAS FOR RVDEFIB IMPEDANCE. DISCUSSED TESTING FOR THIS ISSUE (B)(4). 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
    565296 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS ST. JUDE MEDICAL 7122

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown