BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNIK

    MDR report key: 2784335 · Received October 11, 2012

    Report

    Report Number
    1644487-2012-02597
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    January 1, 2011
    Report Date
    September 17, 2012
    Manufacturer
    CYBERONICS, INC.
    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

    (ABST 1.285.),2012 :ABSTRACT "OUTCOMES OF VAGUS NERVE STIMULATION (VNS) IN PEDIATRIC EPILEPSY" AUTHORS: C. D. YU, I. ABDELMOUMEN, S. RAMGOPAL, C. POWELL, K. REMY, M. LIBENSON, J. MADSEN, A. ROTENBERG, T. LODDENKEMPER INSTIT: MCGILL UNIVERSITY, BOSTON CHILDREN'S HOSPITAL.

    Description of Event or Problem · 1

    AN ABSTRACT ARTICLE WAS RECEIVED FOR REVIEW. THE TITLE WAS."OUTCOMES OF VAGUS NERVE STIMULATION (VNS) IN PEDIATRIC EPILEPSY"AUTHORS: C. D. YU, I. ABDELMOUMEN, S. RAMGOPAL, C. POWELL, K. REMY, M. LIBENSON, J. MADSEN, A. ROTENBERG, T. LODDENKEMPERINSTIT: MCGILL UNIVERSITY, BOSTON CHILDREN'S HOSPITAL. THE ABSTRACT REPORTED CHARTS ABOUT ALL PATIENTS IMPLANTED WITH THE VNS AT A SINGLE CENTER BETWEEN (B)(6) 1997 AND (B)(6) 2011. 252 PATIENTS WERE IDENTIFIED. COMPLETE FOLLOW-UP DATA WAS AVAILABLE FOR 69 PATIENTS. OF THE EXCLUDED PATIENTS, 6 HAD TREATMENT DISCONTINUED DURING THE 12 MONTH FOLLOW-UP PERIOD. REASONS FOR DISCONTINUATION INCLUDED INFECTION (N=3), NAUSEA (N=1), SKIN BREAKDOWN (N=1), AND PERCEIVED LACK OF EFFICACY (N=1). SIXTEEN OF THE 69 PATIENTS EXPERIENCED ADVERSE EFFECTS WHICH DID NOT WARRANT DISCONTINUATION OF THERAPY, INCLUDING VOICE CHANGES, COUGHING, THROAT TICKLE, DIFFICULTY SLEEPING, AND PAIN OVER THE VNS AREA. THIS REPORT IS TO CAPTURE ONE PATIENT WHO DISCONTINUED TREATMENT FOR SKIN BREAKDOWN. AT THIS TIME NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE FULL ARTICLE WAS RECEIVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention