BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 3770333 · Received April 24, 2014

    Report

    Report Number
    1644487-2014-01098
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    January 1, 2013
    Report Date
    April 1, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PEDIATRICIAN RECOMMENDED THE VNS PATIENT UNDERGO OXYGEN THERAPY AND REFERRED THE PATIENT TO ANOTHER PHYSICIAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT WAS HAVING SLEEP APNEA ASSOCIATED WITH STIMULATION. IT IS UNKNOWN WHETHER THE PATIENT HAD SLEEP APNEA PRIOR TO VNS. IT WAS REPORTED THAT THE PATIENT UNDERWENT TWO SLEEP STUDIES ON (B)(6) 2013 AND (B)(6) 2014. THE NEUROLOGIST LAST SAW THE PATIENT IN (B)(6) 2013 AND DIAGNOSTIC RESULTS FROM THE OFFICE VISIT SHOWED NORMAL DEVICE FUNCTION AT THE TIME. NO KNOWN INTERVENTIONS HAVE OCCURRED TO DATE. ATTEMPTS FOR ADDITIONAL RELEVANT INFORMATION WERE MADE BUT HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249006 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS, INC. 105 202592

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other