BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1000447 · Received February 21, 2008

    Report

    Report Number
    1644487-2008-00363
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 17, 2008
    Report Date
    January 22, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT THE PT HAD NOTICED MIGRATION OF HIS VNS DEVICE. FURTHER ASSESSMENT BY THE MEDICAL PROFESSIONAL REVEALED THAT THE DEVICE HAS INDEED MIGRATED "BEHIND THE NIPPLE." ADDITIONALLY, THE REPORTER INDICATED THAT THE LEAD "IS EASILY FELT AND IS VERY TIGHT ACROSS THE PT'S CHEST AREA." IT WAS ALSO REPORTED THAT IT IS DIFFICULT FOR THE PT TO SWALLOW FOOD. THE PT IS TAKING ANALGESIA AS IT IS PAINFUL FOR HIM TO MOVE HIS LEFT ARM. IN ADDITION, THE PT STATED THAT THE STIMULATION SEEMS DIFFERENT. IN ADDITION, REPORTER INDICATED THAT THE PT WAS LAST SEEN IN 2007 AND THE DEVICE DIAGNOSTICS WERE OK AND THE DEVICE WAS "COMFORTABLE IN PT'S CHEST AREA." IT WAS ALSO REPORTED TO THE MANUFACTURER THAT THE PT HAD A FALL IN LATE THAT YEAR AND "IT HAS BEEN UNCOMFORTABLE SINCE THEN."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other