BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 3120475 · Received May 20, 2013

    Report

    Report Number
    1644487-2013-01444
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    January 1, 2012
    Report Date
    April 22, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GARCI´A-NAVARRETE E, ET AL. LONG-TERM RESULTS OF VAGAL NERVE STIMULATION FOR ADULTS WITH MEDICATION-RESISTANT EPILEPSY WHO HAVE BEEN ON UNCHANGED ANTIEPILEPTIC MEDICATION. SEIZURE: EUR J EPILEPSY (2012), HTTP://DX.DOI.ORG/10.1016/ J.SEIZURE.2012.09.008.

    Description of Event or Problem · 1

    AN ARTICLE ENTITLED ¿LONG-TERM RESULTS OF VAGAL NERVE STIMULATION FOR ADULTS WITH MEDICATION-RESISTANCE EPILEPSY WHO HAVE BEEN ON UNCHANGED ANTIEPILEPTIC MEDICATION¿ WAS RECEIVED. FORTY-THREE PATIENTS WERE FOLLOWED. AFTER IMPLANT, PATIENTS WERE EVALUATED ON A MONTHLY BASIS INCREASING STIMULATION 0.25 MA AT EACH VISIT, UP TO 2.5 MA. MEDICATION WAS UNCHANGED FOR AT LEAST 18 MONTHS SINCE THE STIMULATION WAS STARTED. OF THE 43 OPERATED PATIENTS, 63% HAD A SIMULATION OR GREAT THAN 50% REDUCTION IN SEIZURE FREQUENCY. DIFFERENCES IN THE RESPONDER RATE ACCORDING TO STIMULATION INTENSITY, AGE AT ONSET OF EPILEPSY, DURATION OF EPILEPSY BEFORE SURGERY, PREVIOUSLY EPILEPSY SURGERY, AND SEIZURE TYPE, DID NOT REACH STATISTICAL SIGNIFICATIONS. MOST SIDE EFFECTS WERE WELL TOLERATED. ONE PATIENT REPORTED AN INCREASE IN THE DURATION AND INTENSITY OF HIS SEIZURES. TWENTY-TWO PATIENTS EXPERIENCED SIDE-EFFECTS. THE MOST COMMON WERE MILD, CONSISTING IN HOARSENESS, NECK TINGLING OR OCCASIONAL COUGHING AT THE TIME WHEN THE SIGNAL WAS ON, ALL OF WHICH WERE USUALLY WELL TOLERATED. TWO PATIENTS HAD INTERMITTENT DYSPNEA, AND ANOTHER PATIENT EXPERIENCED OCCASIONAL EPISODES OF DYSPHAGIA WITH STIMULATION. IRRITABILITY WAS REPORTED BY TWO FAMILIES, IN THE CONTEXT OF A GENERAL IMPROVEMENT IN THE LEVEL OF ALERTNESS. FIVE HAD SEVERE SIDE EFFECTS, REQUIRING THEIR VNS GENERATORS TO BE INACTIVATED OR EXPLANTED. THREE OF THE 5 PATIENTS THAT STOPPED RECEIVING STIMULATION HAD BEEN RESPONDERS. REASONS FOR EXPLANATION WERE INFECTION IN TWO PATIENTS, AND ODYNOPHAGIA, IN ONE PATIENT. ONE PATIENT HAD AN EXACERBATION OF A PREVIOUS BEHAVIOR DISTURBANCE, WITH SEVERE AGGRESSIVENESS, WHICH IMPROVED WHEN THE STIMULATOR WAS INACTIVATED. SEIZURE REDUCTION WAS MAINTAINED AFTER THE STIMULATION WAS STOPPED. ANOTHER STIMULATOR WAS REMOVED AT FAMILY REQUEST, OWING TO A PERSISTENT ABDOMINAL PAIN. THIS REPORT CAPTURES THE INCREASED SEIZURE DURATION AND INTENSITY: MFR REPORT #1644487-2013-01444. THE EXPLANT DUE TO INFECTION REPORTS ARE CAPTURED IN MFR REPORT #1644487-2013-01450 AND MFR REPORT# 1644487-2013-01453. THE EXPLANT DUE TO ABDOMINAL PAIN IS CAPTURED IN MFR REPORT #1644487-2013-01447. THE EXPLANT DUE TO ODYNOPHAGIA IS CAPTURED IN MFR REPORT #1644487-2013-01449.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221619 PULSE GEN MODEL UNK GENERATOR LYJ CYBERONICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other