BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

    MDR report key: 17520479 · Received August 12, 2023

    Report

    Report Number
    MW5127427
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    October 22, 2013
    Report Date
    December 17, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWS
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS RV LEAD WAS IMPLANTED ON (B)(6) 2012 AND REMAINS IMPLANTED AT THIS TIME. THE PHYSICIAN WAS DR. (B)(6) AT (B)(6) CENTER IN (B)(6), NJ. A CALL TO TECHNICAL SERVICES ON 11/4/2013, STATES THAT DURING A PRE-RADIATION THERAPY CHECK, NOISE WAS NOTED ON RV LEAD. EVENT STORED ON OCTOBER 22ND. SOME NOISE WAS REPRODUCIBLE WITH ISOMETRIC, BUT NOT SENSED BY DEVICE. NOISE ON STORED EVENTS WAS QUITE DIFFERENT. LEAD IMPEDANCE IS STABLE. NO OTHER INFORMATION IS AVAILABLE. 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
    870140 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS ST. JUDE MEDICAL 7121

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown