BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 6976246 · Received October 25, 2017

    Report

    Report Number
    1644487-2017-04678
    Event Type
    Injury
    Date Received
    October 25, 2017
    Date of Event
    January 1, 2017
    Report Date
    October 25, 2017
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FORDE, INGA C, ET AL. ¿A POTENTIAL NOVEL MECHANISM FOR VAGUS NERVE STIMULATOR-RELATED CENTRAL SLEEP APNEA.¿ CHILDREN, VOL. 4, NO. 10, SER. 86, 29 SEPT. 2017. 86.

    Description of Event or Problem · 1

    A CASE STUDY WAS RECEIVED WHICH DETAILED THE EXPERIENCE OF A VNS PATIENT. A YEAR AFTER IMPLANT THE PATIENT¿S MOTHER NOTICED THAT THE PATIENT HAD AN ALTERED BREATHING PATTERN. THE PATIENT DID NOT HAVE ANY SLEEP COMPLAINTS. A SLEEP STUDY WAS ORDERED WHICH SHOWED INTERMITTENT ACTIVATION OF THE VNS DURING SLEEP WAS SEEN TO TRIGGER EPISODES OF TACHYPNEA WITH CONSEQUENT POST-HYPERVENTILATION CENTRAL APNEA. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757694 PULSE GEN MODEL UNK GENERATOR LYJ CYBERONICS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR