BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

    MDR report key: 17518145 · Received August 12, 2023

    Report

    Report Number
    MW5125093
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    March 31, 2014
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWS
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THIS DEVICE WAS IMPLANTED ON (B)(6) 2011 AND REMAINS IMPLANTED AT THIS TIME. PHYSICIAN CONTACTED TECHNICAL SERVICES TO REPORT THE DELIVERY OF HIGH VOLTAGE THERAPY, LOSS OF CAPTURE AT AN OUTPUT OF 1 .25MS AT 1 .OMS. THE PHYSICIAN WAS DR. (B)(6) AT (B)(6) MEDICAL CENTER IN (B)(6) . NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. 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
    2192708 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS ST. JUDE MEDICAL CD1231-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown