BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1760635 · Received July 14, 2010

    Report

    Report Number
    1644487-2010-01619
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    January 1, 2008
    Report Date
    June 14, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE VNS PATIENT'S CAREGIVER THAT THE PATIENT, WHO WAS INITIALLY IMPLANTED WITH VNS IN 2004, HAS HAD SLEEP APNEA FOR ABOUT TWO YEARS NOW. THE REPORTER INDICATED THAT IT HAS GOTTEN PROGRESSIVELY WORSE AND THAT IN THE PAST, A NASAL SPRAY WAS USED TO HELP THE APNEA, HOWEVER, SHE HAS NOTED FULL CESSATION OF RESPIRATION LATELY. THE CAREGIVER STATED THAT THE NEUROLOGIST WHO MANAGES THE VNS DEVICE HAS NOT BEEN MADE AWARE OF THE SLEEP APNEA. ADDITIONALLY, THE CAREGIVER STATED THAT THE PATIENT'S ENT AND PRIMARY CARE PHYSICIAN BELIEVE THAT THE SLEEP APNEA WAS CAUSED BY THE VNS DEVICE DUE TO THE INTERACTION WITH THE SYMPATHETIC NERVE CHAIN. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE TREATING NEUROLOGIST HAVE BEEN MADE, BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO DATE. FURTHER FOLLOW UP WAS DONE WITH THE PATIENT'S ENT PHYSICIAN. THE ENT'S NURSE NOTED FROM THE PATIENT'S CHART THAT A SLEEP STUDY WAS DONE IN 2008, WHICH DID CONFIRM SLEEP APNEA. THERE WAS NO INFORMATION IN THE PATIENT'S CHART REGARDING THE VNS DEVICE, OR THE PHYSICIAN'S ASSESSMENT ON THE RELATIONSHIP OF THE EVENT TO VNS. IT WAS ADDITIONALLY NOTED THAT THE PATIENT IS NOW ON A CPAP TITRATION, AND IT WAS NOTED THAT THE PATIENT ALSO HAS SINUSITIS, AND OTITIS MEDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 9405

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention