BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

    MDR report key: 17519367 · Received August 12, 2023

    Report

    Report Number
    MW5126315
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    June 20, 2017
    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) 2013 AND REMAINS IMPLANTED AT THE TIME. A CALL WAS PLACED TO TECHNICAL SERVICES ON 4/18/2017 STATING THAT SOME NOISE NOTED ON RV LEAD. THE PHYSICIAN WAS DR. SUNIL JHA AT METHODIST UNIVERSITY HOSPITAL IN MEMPHIS, TN. 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
    563618 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS ST. JUDE MEDICAL 7122Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown