BEUDAMED
    FDA Adverse Event Death Summary report: N

    LENIRE

    MDR report key: 19072661 · Received April 9, 2024

    Report

    Report Number
    3018030059-2024-00001
    Event Type
    Death
    Date Received
    April 9, 2024
    Date of Event
    February 23, 2024
    Report Date
    April 9, 2024
    Manufacturer
    NEUROMOD DEVICES LIMITED
    Product Code
    QVN
    PMA / PMN Number
    DEN210033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED BY THE HEALTHCARE PROFESSIONAL: "1. EVENT DESCRIPTION: PATIENT TOOK HIS OWN LIFE ON (B)(6) 2024. 2. DATE OF INCIDENT: THE SPECIFIC DATE ON WHICH THE SUICIDE OCCURRED, TO THE EXTENT THAT THIS INFORMATION IS AVAILABLE. 3. DATE OF AWARENESS (HEALTHCARE PROFESSIONAL): (B)(6) 2024. 4. SOURCE OF REPORT: (B)(6) CALLED THE PATIENT FOR A SCHEDULED PROGRESS CHECK IN. HIS SPOUSE ANSWERED THE PHONE AND LET US KNOW THAT THE PATIENT HAD TAKEN HIS LIFE. 5. PATIENT INFORMATION: (B)(6), (B)(6) 1956, (B)(6). 6.DEVICE'S INVOLVEMENT: THERE WERE NO MALFUNCTIONS OR FAILURES OF THE DEVICE. THE ONLY INVOLVEMENT IS THAT THE PATIENT CAME TO US SEEKING LENIRE TINNITUS TREATMENT AND WAS FIT AND BEGAN TREATMENT WITH THE DEVICE. HE WAS SEEN FOR A COMPREHENSIVE TINNITUS EVALUATION AND FIT WITH LENIRE ON (B)(6) 2024. CHART NOTE FROM TELEPHONE CHECK IN ON (B)(6)2024: LENIRE 2 WEEK CHECK IN: PATIENT REPORTED THAT HE'S BEEN DOING HIS TREATMENTS TWICE A DAY - ONCE IN THE AM AND ONCE IN THE PM. HE REPORTED HE'S NOTICED A SPIKE IN THE TINNITUS AFTER THE MORNING SESSION, AND IT LASTS ABOUT 30 MINS. HE SAID THAT RECENTLY HE'S TURNED A CORNER IN SLEEP AND IT'S STARTING TO IMPROVE. PATIENT HAS VERY REALISTIC EXPECTATIONS AND WILL CONTINUE TREATMENT. RETURN TO CLNIC IN 1 MONTH FOR IN-PERSON VISIT".

    Description of Event or Problem · 0

    PATIENT TOOK HIS OWN LIFE ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288677 LENIRE LENIRE QVN NEUROMOD DEVICES LIMITED CR-201

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Death