BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3212285 · Received July 9, 2013

    Report

    Report Number
    1644487-2013-02029
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 1, 2011
    Report Date
    June 14, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT DUE TO THE PATIENT'S EXPERIENCE WITH IRREGULAR HEART RHYTHMS THE CARDIOLOGIST DID AN ABLATION. FOLLOWING THE ABLATION THE PATIENT BEGAN TO HAVE A LOW HEART RATE AND A PACEMAKER WAS IMPLANTED. AFTER HAVING THE PACEMAKER IMPLANTED THE PATIENT STARTED TO BECOME DIZZY, SLEEPY, WITH TROUBLE EATING (WEIGHT LOSS), AND VOMITS WITH DIZZINESS. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED THEIR SHOULDER AND NECK TIGHTENING UP WHEN THEY SWIPED THE VNS MAGNET ACROSS THE GENERATOR.GOOD FAITH ATTEMPTS ARE CURRENTLY BEING PERFORMED.

    Description of Event or Problem · 1

    FOLLOW UP WITH THE PHYSICIAN FOUND THAT HE WAS NOT UNDER THE IMPRESSION THAT THE PATIENT'S COMPLAINTS OF EXPERIENCING IRREGULAR HEART RHYTHMS, DIZZINESS (WHICH LED TO VOMITING), SLEEPINESS, INABILITY TO EAT (LEADING TO WEIGHT LOSS), OR TIGHTENING OF SHOULDER AND NECK AREA WERE RELATED TO THE PATIENT'S VNS. THE PHYSICIAN STATED THAT THE PATIENT HAS HAD EXTENDED PERIODS IN WHICH HE WAS ASYMPTOMATIC WITH HIS DEVICE TURNED ON, AND, CONVERSELY, HE HAS REPORTED THE ABOVE SYMPTOMS WITH HIS DEVICE DISABLED. IT IS THE PHYSICIAN'S UNDERSTANDING THAT THE PATIENT IS CURRENTLY UNDERGOING A CARDIAC WORKUP TO EXPLORE A CARDIOVASCULAR ETIOLOGY FOR HIS COMPLAINTS. LASTLY, THE PHYSICIAN STATED THAT AS HE BELIEVES NONE OF THE PATIENT'S PROBLEMS ARE CAUSED BY HIS VNS, HE IS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312971 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 201513

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention