BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 1243690 · Received November 25, 2008

    Report

    Report Number
    1644487-2008-02856
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    October 23, 2008
    Report Date
    October 27, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THAT HE WAS IMPLANTED WITH VNS IN 2008. HE SAID THERE IS FLAKING IN HIS NECK AREA. HE IS NOT SURE IF IT IS DERMABOND OR HIS SKIN. HE ALSO REPORTS HE CAN'T STRAIGHTEN HIS LEFT ARM OUT LIKE HE USED TO AND HIS NECK IS SORE ON THE LEFT SIDE. IT IS UNK IF THE PT NOT BEING ABLE TO STRAIGHTEN THEIR LEFT ARM IS A PERMANENT OR TEMPORARY ISSUE. REPORTED POSTOPERATIVE SO UNK IF RELATED TO NORMAL SURGICAL RECOVERY PROCESS. GOOD FAITH ATTEMPTS ARE BEING MADE TO ATTAIN ADD'L DETAILS ABOUT THE REPORTED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS, INC. 103 200873

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR