BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNKNOWN

    MDR report key: 24988574 · Received April 24, 2026

    Report

    Report Number
    1644487-2026-10512
    Event Type
    Malfunction
    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
    Product Problem
    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 4 REPORTED INSTANCES OF GENERATOR MALFUNCTION AND REPLACEMENT. MFR-REPORT#1644487-2026-10511 WILL CAPTURE THE REPORTED INSTANCES OF LEAD FRACTURE AND HIGH IMPEDANCE. MFR-REPORT#1644487-2026-10510 WILL CAPTURE THE REPORTED INFECTION REQUIRING REPLACEMENT. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583153 PULSE GEN MODEL UNKNOWN GENERATOR LYJ LIVANOVA USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown