BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 105

    MDR report key: 3792218 · Received May 6, 2014

    Report

    Report Number
    1644487-2014-01180
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 8, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT DEVELOPED APATHY AND ANOREXIA AFTER HIS DEVICE WAS FIRST PROGRAMMED ON. THE PHYSICIAN IS LOOKING AT MULTIPLE POSSIBLE ETIOLOGIES. THE PATIENT HAS PITUITARY DYSFUNCTION DUE TO SIX BRAIN SURGERIES FOR A PINEALOMA. THE PATIENT¿S DEVICE WAS PROGRAMMED OFF DURING AN OFFICE VISIT ON (B)(6) 2014. FURTHER FOLLOW-UP REVEALED THAT THE PATIENT WAS LAST SEEN ON (B)(6) 2014. AT THAT TIME, IT WAS NOTED THAT THE PATIENT HAD GAINED WEIGHT AND HAD IMPROVED MENTAL STATUS SINCE THE DEVICE WAS PROGRAMMED OFF. THE PATIENT WAS PREVIOUSLY OVERWEIGHT AND HAD BEEN VERY TALKATIVE. CLINIC NOTES FROM THE PATIENT¿S OFFICE VISIT STATED THAT THE PATIENT¿S ISSUES WERE LIKELY NOT RELATED TO VNS AS THE PATIENT¿S DEVICE SETTINGS WERE VERY LOW. IT WAS ALSO NOTED THAT THE PATIENT HAD RECENTLY MOVED, AND THIS MAY HAVE HAD AN EFFECT ON THE REPORTED EVENTS. THE PATIENT¿S DEVICE WAS TO REMAIN PROGRAMMED OFF UNTIL THE PATIENT¿S NEXT OFFICE VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272516 PULSE GEN MODEL 105 GENERATOR LYJ CYBERONICS INC 105 3811

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention