BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 2903526 · Received January 9, 2013

    Report

    Report Number
    1644487-2013-00100
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 10, 2012
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A MANUSCRIPT TITLED "EFFICACY OF VAGUS NERVE STIMULATION IN INTRACTABLE EPILEPSY PATIENTS IN CYPRUS" WAS RECEIVED BY THE MANUFACTURER FOR REVIEW. THE ARTICLE DISCUSSES EFFICACY OF VNS OVER TIME, WHICH WAS ANALYZED IN 27 PATIENTS. WITHIN THE SECTION TITLED "SURGICAL RESULTS, COMPLICATIONS, AND DEVICE REMOVALS," IT WAS REPORTED THAT ONE PATIENT HAD VNS REMOVED DUE TO OCCASIONAL NECK PAIN RELATED TO DUTY CYCLE. IT WAS FOUND AMONG THE PATIENTS THAT EXHIBITED THIS SYMPTOM THAT UPON ALTERATION OF THE VNS PARAMETERS THE PAIN SYMPTOMS WOULD USUALLY SUBSIDE. IT IS UNCLEAR FROM THE MANUSCRIPT IF THE EXPLANT WAS TAKEN FOR PATIENT COMFORT OR TO PRECLUDE A SERIOUS INJURY. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. THE REPORT OF ONE PATIENT WHO DEVELOPED AN INFECTION IS CAPTURED IN MFG REPORT NUMBER: 1644487-2013-00102. THE REPORT OF ONE PATIENT WHO HAD VNS EXPLANTED DUE TO DYSPHAGIA ASSOCIATED WITH VNS STIMULATION IS CAPTURED IN MFG REPORT NUMBER: 1644487-2013-00103. THE REPORTS OF TWO PATIENTS WHO DIED OF SUDDEN UNEXPECTED DEATH IN EPILEPSY (SUDEP) ARE CAPTURED IN MFG REPORT NUMBERS: 1644487-2013-00104 AND 1644487-2013-00105. THE REPORT OF ONE FOCAL PATIENT WHO HAD 0% CHANGE IN THE SEIZURE FREQUENCY OR WORSENING OF SEIZURES IS REPORTED IN MFG REPORT NUMBER: 1644487-2013-00101.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12654 PULSE GEN MODEL UNK GENERATOR LYJ CYBERONICS ASKU NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention