BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

    MDR report key: 17518034 · Received August 11, 2023

    Report

    Report Number
    MW5124982
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Date of Event
    May 17, 2018
    Report Date
    July 10, 2018
    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) 2005 AND WAS CAPPED ON (B)(6) 2018 DUE TO AN UNKNOWN PRODUCT PERFORMANCE ISSUE. THE PHYSICIAN WAS DR. KARL LLG AT GENESYS REGIONAL MEDICAL CENTER IN GRAND BLANC ML. 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
    869986 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS ST. JUDE MEDICAL 1582

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown