BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD MODEL UNKNOWN

    MDR report key: 1894925 · Received November 5, 2010

    Report

    Report Number
    1644487-2010-02505
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 5, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY A RADIOLOGIST THAT THE PT'S STERNOCLEMASTOID MUSCLE APPEARED TO BE LARGER THAN NORMAL BELOW THE ELECTRODES AND NORMAL SIZE ABOVE THE ELECTRODES. HE DENIED THE APPEARANCE OF ANY INFECTION AT THAT TIME. HE ALSO STATED THE PT IS COMPLAINING OF PAIN AT THE NECK INCISION. F/U WITH THE TREATING PHYSICIAN REVEALED THAT THE PT SHOWED INFECTION AFTER A FEW DAYS. CULTURES WERE TAKEN AND THEY SHOWED SIGNS OF INFECTION. PHYSICIAN DID NOT KNOW THE RESULT OF CULTURES. HE STATED THAT THE INFECTION WAS LIKELY RELATED TO SURGERY. NO PT MANIPULATION OR TRAUMA WAS REPORTED. THEY TREATED THE INFECTION WITH ANTIBIOTICS AND DRAINED OUT THE PUS. PER PHYSICIAN, PAIN WAS LIKELY RELATED TO THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL UNKNOWN LYJ CYBERONICS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention