BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNKNOWN

    MDR report key: 21720338 · Received March 28, 2025

    Report

    Report Number
    1644487-2025-00343
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    January 14, 2022
    Report Date
    March 28, 2025
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TATE WB, WARD K, SNIDER ZG. A TEEN WITH TRISOMY 18: CHALLENGES AND TRIUMPHS OF A LONG LIFE WITH EDWARDS SYNDROME. CUREUS. 2025 JAN 14;17(1): E77417. DOI: 10.7759/CUREUS.77417. PMID: 39949455; PMCID: PMC11822554. LIVANOVA USA, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT LIVANOVA HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION, OR A CONCLUSION BY FDA OR ANYONE ELSE, THAT THE DEVICE, LIVANOVA, OR LIVANOVA'S EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR "MALFUNCTIONS". THESE WORDS ARE INCORPORATED INTO THE FDA 3500A MEDWATCH FORM BY THE FDA, AND LIVANOVA OBJECTS TO THEIR USE.

    Description of Event or Problem · 0

    DURING A REVIEW OF A SCIENTIFIC ARTICLE TITLED "A TEEN WITH TRISOMY 18: CHALLENGES AND TRIUMPHS OF A LONG LIFE WITH EDWARDS SYNDROME" IT WAS DISCOVERED THAT THE PATIENT WAS IMPLANTED WITH VNS THERAPY. IN THIS ARTICLE, AN INCREASE IN SEIZURE FREQUENCY WAS REPORTED AFTER AN INITIAL EFFICACY WITH THE VNS WAS REPORTED. IT IS UNKNOWN IF THE VNS HAD ATTRIBUTED TO THIS INCREASE IN SEIZURES REPORTED. OF NOTE, IT WAS NOTED THAT PATIENT'S FAMILY WAS COUNSELED TO PURSUE PALLIATIVE CARE UPON HER BIRTH DUE THEIR DIAGNOSIS. THE FAMILY OPTED FOR SURGICAL MANAGEMENT WHICH INCLUDED THE PLACEMENT OF VNS ALONG WITH OTHER MEASURES. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2613132 PULSE GEN MODEL UNKNOWN GENERATOR LYJ LIVANOVA USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female