BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 3121270 · Received May 20, 2013

    Report

    Report Number
    1644487-2013-01462
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    January 1, 1996
    Report Date
    April 22, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THYGESEN KS, SABERS A. PROMISING EFFECT OF VAGAL STIMULATION IN DANISH PATIENTS WITH EPILEPSY. DAN MED J. 2013;60(3):A4597. HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/23484615.

    Description of Event or Problem · 1

    AN ARTICLE ENTITLED ¿PROMISING EFFECT OF VAGAL STIMULATION IN DANISH PATIENTS WITH EPILEPSY¿ WAS RECEIVED. THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFECT OF VNS ON SEIZURE FREQUENCY AND TO INVESTIGATE PATIENT SATISFACTION OF AND QUALITY OF LIFE EFFECTS OF VNS TREATMENT. 94 PATIENTS WERE REVIEWED BETWEEN 1996 AND 2006. 46 PATIENTS EXPERIENCED A REDUCTION IN SEIZURE FREQUENCY AND 38% OF ADULTS REPORTED A POSITIVE EFFECT ON QUALITY OF LIFE WITH A BENEFIT ON LONG-TERM TREATMENT. AROUND 20% ALSO REPORTED A POSITIVE EFFECT ON QUALITY OF LIFE MEASURE LIKE COPYING, MOOD, SELF-CONFIDENCE, AND SOCIAL ABILITIES. IN THE CHILDREN¿S GROUP, 21% REPORT A POSITIVE EFFECT ON QUALITY OF EVERYDAY LIFE FOR THE CHILD AND THE FAMILY, 52-55% REPORTED NO CHANGE AND 10% A NEGATIVE EFFECT. THE PATIENTS HAD MILD SIDE EFFECTS, EXPECT FOR ONE CASE OF VOCAL CORD PARALYSIS. RESULTS ALSO INDICATED THAT TWO CHILDREN WERE REPORTED AS HAVING SUFFERED AN INCREASE IN THE FREQUENCY OF SEIZURES. ANOTHER PATIENT HAD THE VNS REMOVED DUE TO MENTAL SIDE EFFECTS AND EXPERIENCED AN INCREASE IN THE FREQUENCY OF SEIZURES. ADDITIONAL SIDE EFFECTS INCLUDED ONE CASE OF INFECTION, BEHAVIORAL CHANGES, HOARSENESS WITH STIMULATION, STIMULATION DEPENDENT DYSPNEA UPON EXERTION, COSMETIC COMPLAINS, LOSS OF SINGING ABILITY, DIFFICULTIES SWALLOWING, DIFFICULTIES SPEAKING, AND RED, WIDE, OR ITCHY SCARS. THE AUTHORS SUGGEST THAT THE LOSS OF SINGING ABILITY COULD BE DUE TO VOCAL CORD PARALYSIS OR HOARSENESS. ONE INCREASE IN SEIZURES IS CAPTURED THIS REPORT: MFR REPORT #1644487-2013-01462 ANOTHER INCREASE IN SEIZURES IS CAPTURED IN MFR REPORT #1644487-2013-01461 THE INCREASE IN SEIZURES WITH MENTAL SIDE EFFECTS IS CAPTURED IN MFR REPORT #1644487-2013-01460 THE VOCAL CORD PARALYSISIS CAPTURED IN MFR REPORT #1644487-2013-01459. THE REPORT OF INFECTION IS CAPTURED IN MFR REPORT # 1644487-2013-01463 THE REPORT OF LOSS OF ABILITY TO SING POSSIBLY DUE TO VOCAL CORD PARALYSIS IS CAPTURED IN MFR REPORT #1644487-2013-01464

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222352 PULSE GEN MODEL UNK GENERATOR LYJ CYBERONICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1