BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102R

    MDR report key: 1120672 · Received August 14, 2008

    Report

    Report Number
    1644487-2008-01865
    Event Type
    Injury
    Date Received
    August 14, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 18, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER THAT THE VNS PATIENT WAS EXPERIENCING A RECENT INCREASE IN SEIZURE ACTIVITY; RELATIONSHIP TO PRE-VNS BASELINE IS UNKNOWN. THE GROUP HOME, WHERE THE PATIENT RESIDES, REPORTED THE INCREASE IN SEIZURES EVENT TO THE PATIENTS TREATING NEUROLOGIST. A BATTERY LIFE CALCULATION WAS PERFORMED WITH THE AVAILABLE PROGRAMMING HISTORY AND REVEALED THAT THE GENERATOR WAS NOT LIKELY NEARING END OF SERVICE. FURTHER FOLLOW UP WITH THE TREATING PHYSICIAN REVEALED THAT THE PATIENT WAS SEEN FOLLOWING THE ONSET OF THE EVENT AND DIAGNOSTIC TESTS PERFORMED REVEALED NORMAL DEVICE FUNCTION. THE PATIENT WAS NOT ABLE TO TOLERATE AN INCREASE IN OUTPUT CURRENT. DEVICE SETTINGS AND MEDICATIONS WERE ADJUSTED AND THE SEIZURE ACTIVITY HAS IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102R LYJ CYBERONICS, INC. 102R 016999

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention