BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNKNOWN

    MDR report key: 24988551 · Received April 24, 2026

    Report

    Report Number
    1644487-2026-10510
    Event Type
    Injury
    Date Received
    April 24, 2026
    Date of Event
    November 30, 2011
    Report Date
    April 24, 2026
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BARRIT S, ZANELLO M, CARRON R. VAGUS NERVE STIMULATION LEAD DURABILITY: INSIGHTS FROM AN EXTENSIVE MONOCENTRIC SINGLE-OPERATOR ADULT SERIES. NEUROCHIRURGIE. 2025 JAN;71(1):101631. DOI: 10.1016/J.NEUCHI.2025.101631. EPUB 2025 JAN 3. PMID: 39756614.

    Description of Event or Problem · 0

    A SCIENTIFIC ARTICLE TITLED "VAGUS NERVE STIMULATION LEAD DURABILITY: INSIGHTS FROM AN EXTENSIVE MONOCENTRIC SINGLE-OPERATOR ADULT SERIES." WAS IDENTIFIED DURING LITERATURE REVIEW CONTAINING COMPLAINTS FOR MULTIPLE VNS PATIENTS. THE ARTICLE CONTAINED REPORTS OF 2 INSTANCES OF HIGH IMPEDANCE REQUIRING REVISION, 1 INSTANCE OF LEAD FRACTURE REQUIRING REVISION, 1 INSTANCE OF LEAD FRACTURE LEADING TO EXPLANT, 4 REPORTS OF GENERATOR MALFUNCTION REQUIRING GENERATOR REPLACEMENT, AND 1 REPORT OF INFECTION REQUIRING GENERATOR REPLACEMENT. NO PATIENT OR PRODUCT INFORMATION WAS AVAILABLE IN THE ARTICLE AND THE PATIENT'S COULD NOT BE IDENTIFIED. THIS REPORT WILL CAPTURE THE REPORTED INFECTION REQUIRING REPLACEMENT. ANOTHER REPORT WILL BE CREATED TO CAPTURE THE REPORTED GENERATOR MALFUNCTIONS. A SEPARATE REPORT WILL BE CREATED TO CAPTURE THE REPORTED LEAD FRACTURES AND HIGH IMPEDANCE. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583228 PULSE GEN MODEL UNKNOWN GENERATOR LYJ LIVANOVA USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention