BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2873224 · Received December 13, 2012

    Report

    Report Number
    1644487-2012-03343
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    May 18, 2012
    Report Date
    November 16, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MOTHER OF A VNS PATIENT VIA OUR LOCAL DISTRIBUTOR IN (B)(4) REPORTED THAT SINCE THEIR CHILD HAD KIDNEY REMOVAL SURGERY, THEY HAVE NOT BEEN AS STABLE AS BEFORE AND HAS HAD AN INCREASED SEIZURE FREQUENCY AND SEIZURE INTENSITY. THE PATIENT HAD ONE OF HER KIDNEYS REMOVED ON (B)(6) 2012 DUE TO AN INFECTION. BEFORE THE SURGERY, THE PATIENT'S GENERATOR WAS TURNED OFF FOR SIX AND A HALF HOURS IN ORDER TO PREVENT AND AVOID ANY INTERFERENCE WITH THE ELECTROCAUTERY. REGARDING THE PHARMACOLOGICAL TREATMENT, THE PATIENT'S MEDICATIONS WERE SUSPENDED IMMEDIATELY BEFORE SURGERY AND ONLY CONTROLLED WITH ONE TYPE. THE MEDICATIONS WERE REINCORPORATED AND INCREASED IN THEIR DOSAGE AFTER THE SURGERY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AS THE PATIENT HAS NOT SEEN HER PHYSICIAN REGARDING THESE ISSUES YET AND THE PATIENT SPECIFICALLY REQUESTED THE PHYSICIAN NOT BE CONTACTED REGARDING THESE EVENTS.

    Description of Event or Problem · 1

    FOLLOW UP WITH THE PHYSICIAN FOUND THAT IN THE PHYSICIAN'S OPINION, THE "SUPPOSED" INCREASE IN SEIZURE FREQUENCY WAS MORE LIKELY RELATED TO MOOD DISORDERS ASSOCIATED WITH THE PATIENT'S AGE RATHER THAN VNS THERAPY. IT WAS SPECIFIED THAT THE INCREASE IN SEIZURE FREQUENCY WAS "SUPPOSED", BECAUSE IN THE PHYSICIAN'S OPINION THE PERCEPTION OF THE PARENTS CONCERNING THE RELEVANT ASPECTS OF THERAPY IS SUBJECTIVE. IT WAS STATED THAT RISPERIDONE WAS INTRODUCED INTO THE PATIENT'S MEDICATION REGIME AND NO CHANGES TO VNS SETTINGS WERE PERFORMED. IT WAS CONFIRMED THAT THE INCREASED SEIZURE INTENSITY WAS ALSO NOT RELATED TO VNS THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 015424

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization| R