BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 3116299 · Received May 16, 2013

    Report

    Report Number
    1644487-2013-01384
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    January 1, 2010
    Report Date
    April 17, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE PHYSICIAN WHO WAS EDITOR-IN-CHIEF OF THE ARTICLE AT THAT TIME WHO REPORTED THAT THE DATA REGARDING VNS COMPLICATIONS WAS NOT OBTAINED FROM THE VNS THERAPY OUTCOME REGISTRY MAINTAINED BY CYBERONICS, INC. OR VNS THERAPY LABELING. THE PHYSICIAN INDICATED THE CITATION IS FROM THE FOLLOWING ARTICLE: FISHER RS, HANDFORTH A. "REASSESSMENT: VAGUS NERVE STIMULATION FOR EPILEPSY: A REPORT OF THE THERAPEUTICS AND TECHNOLOGY ASSESSMENT SUBCOMMITTEE OF THE AMERICAN ACADEMY OF NEUROLOGY. NEUROLOGY 1999; 53:6669." THIS ARTICLE DETAILS THE RANDOMIZED, CONTROLLED, MULTI-CENTER CLINICAL TRIAL, CALLED E03 AND E05 DOUBLE-BLINDED STUDIES CONDUCTED BY THE MANUFACTURER OF VNS THERAPY WITH THE DATA PROVIDED FROM THE MANUFACTURER. THEREFORE, THE DATA HAS ALREADY BEEN REPORTED TO THE FDA, AND THIS IS THE DATA THAT THE PHYSICIAN OBTAINED THE INFORMATION FROM IN WHICH HE INCLUDED THE EDITOR-IN-CHIEF'S NOTES.

    Description of Event or Problem · 1

    AN ARTICLE FROM A CONSUMER JOURNAL ("EPILEPSY: INSIGHTS AND STRATEGIES") PUBLISHED IN AUGUST 2010 TITLED "HOW GETTING A VAGUS NERVE STIMULATOR AND A REFOCUS ON HELPING OTHERS - TURNED MY LIFE AROUND" WRITTEN BY A VNS PATIENT WITH EDITOR'S NOTES BY A VNS TREATING PHYSICIAN. IN THE EDITOR'S NOTE, THE PHYSICIAN REPORTED THAT "COMPLICATIONS CAN OCCUR WITH THE IMPLANT PROCEDURE OR WITH STIMULATION. SOME PEOPLE HAVE HAD INFECTIONS, BREATHING PROBLEMS OR HEART IRREGULARITIES: THE RELATION TO THE STIMULATION IS SOMETIMES UNCERTAIN." THE REPORT OF HEART IRREGULARITIES IS CAPTURED IN MFG REPORT NUMBER: 1644487-2013-01385, AND THIS REPORT CAPTURES THE INFECTIONS. THESE ARE KNOWN EVENTS ADDRESSED IN MANUFACTURER LABELING. ATTEMPTS FOR ADDITIONAL INFORMATION FROM THE PHYSICIAN REGARDING WHETHER THIS INFORMATION WAS OBTAINED FROM MANUFACTURING LABELING OR OUTCOME REGISTRY OR OBTAINED FROM THE PHYSICIAN'S PATIENTS' EXPERIENCES HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217566 PULSE GEN MODEL UNK GENERATOR LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other