BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2063786 · Received April 15, 2011

    Report

    Report Number
    1644487-2011-00821
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 18, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINIC NOTES THAT THE PATIENT HAS HAD SOME "AGGRESSION ISSUES" TO THE POINT THAT SHE CUT BOTH OF HER WRISTS. CURRENTLY, SHE SAYS THAT SHE WAS TRYING TO HURT HERSELF AND SHE RECALLS WHY SHE HAD TO COME OFF OF THE ZONEGRAN IN THE PAST. IT WAS ALSO NOTED THAT THE PATIENT IS CURRENTLY HAVING SOME MARITAL DIFFICULTIES. THE VNS WAS INTERROGATED BY THE PHYSICIAN, BUT NO CHANGES WERE MADE TO SETTINGS AND NO DIAGNOSTICS WERE PERFORMED PER PATIENT REQUEST. ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS INC 102 8350

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Life Threatening