BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL UNK

    MDR report key: 2254060 · Received September 19, 2011

    Report

    Report Number
    1644487-2011-02212
    Event Type
    Injury
    Date Received
    September 19, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 24, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THE PATIENT'S SUICIDE ATTEMPT WAS NOT RELATED TO VNS BUT TO DISEASE PROCESS. THE PATIENT IS GOING THROUGH A DIVORCE, HAVING CHILD CUSTODY ISSUES, AND IS VERY STRESSED. THE PATIENT'S MEDICATION LEVELS ARE ALSO NOT IN A THERAPEUTIC RANGE. THE REPORTER IS AWARE OF THE ILLICIT DRUG USE AND THE PATIENT IS BEING COUNSELED. THE VNS IS WORKING PROPERLY PER THE REPORTER BUT SPECIFICS AND DEVICE INFORMATION WERE NOT PROVIDED. THE REPORTER INDICATED THE VNS HAS BEEN HELPFUL FOR THE PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THAT THE PATIENT'S ATTEMPTED TO OVERDOSE ON PCP (PHENCYCLIDINE).

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS PATIENT WAS ADMITTED TO AN INPATIENT FACILITY DUE TO A SUICIDE ATTEMPT FROM INGESTING RECREATIONAL DRUGS.THE PATIENT WAS INITIALLY IMPLANTED WITH VNS ON (B)(6) 2011.ATTEMPTS FOR FURTHER INFORMATION ARE IN PROGRESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization| L| R