BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA

    MDR report key: 17532661 · Received August 12, 2023

    Report

    Report Number
    MW5139568
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    July 5, 2022
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWS
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    Q: PT WAS IN OFFICE FOR TESTING, AND COULD NOT ACHIEVE CONSISTENT CAPTURE AT 5V@ 1.0 1MS. WILL DEVICE STILL SHOCK SUCCESSFULLY? 0: LEAD IMPEDANCE HAVE BEEN STABLE, NO NOISE VISIBLE ON EGM, NO SIC OR ANY OTHER SIGNS OF LEAD ISSUE. CALLER SAYS R-WAVE AMPLITUDE HAS DECREASED, BUT STILL AROUND 7 MV. R: DISCUSSED SHOCK DELIVER USES COMPLETELY INDEPENDENT ELECTRODES FROM PACING/SENSING ELECTRODES AN HIGH PACING CAPTURE SHOULDN'T AFFECT SHOCK DELIVERY. DISCUSSED THAT ATP MAY NOT BE SUCCESSFUL. DISCUSSED THAT SINCE THIS IS A SU LEAD, THAT CALLER SHOULD CONTACT STJ TECHSERV TO SEE IF THIS IS A SYMPTOM OF ANY OF THEIR LEAD FAILURE ISSUES. (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
    1354388 DURATA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS ST. JUDE MEDICAL 7122 DURATA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown