BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 2895522 · Received January 3, 2013

    Report

    Report Number
    1644487-2013-00044
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 4, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE INCREASE IN DEPRESSION WAS ABOVE PRE-VNS BASELINE BUT WAS NOT RELATED TO VNS. THE PATIENT HAS LOST HIS JOB AND HAD A CLOSE FAMILY MEMBER PASS AWAY AND THE INCREASE IN DEPRESSION IS RELATED TO THAT AND OTHER EXTERNAL STRESSORS. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS HAVING A INCREASE IN DEPRESSION. CLINIC NOTES REPORTED THAT THE PATIENT HAS BEEN VERY DEPRESSED FOR AT LEAST THE LAST 10 YEARS BUT IS NOW MORE DEPRESSED. IT IS UNCLEAR IF THE WORSENING OF DEPRESSION IS RELATED TO VNS. THE PATIENT HAS REFUSED TREATMENT YEARS AGO BUT IS NOW WILLING TO ACCEPT TREATMENT NOW. I THE PAST HE HAS BEEN HOSPITALIZED AND PUT INTO RESTRAINT FOR HIS DEPRESSION. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2588 PULSE GEN MODEL 102R GENERATOR LYJ CYBERONICS, INC. 102R 10960

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R