BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2893652 · Received January 2, 2013

    Report

    Report Number
    1644487-2013-00009
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    January 24, 2012
    Report Date
    December 13, 2012
    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

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    FURTHER FOLLOW-UP REVEALED THAT THE PHYSICIAN INDICATED THAT THE PATIENT'S SEIZURES HAVE IMPROVED WITH VNS THERAPY. NO INTERVENTIONS WERE TAKEN FOR THE INCREASE IN SEIZURES; HOWEVER, THE PHYSICIAN INDICATED THAT THE PATIENT'S MEDICATION COMPLIANCE WAS ACCENTUATED.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6), 2012 INDICATED THAT THE PATIENT WAS EXPERIENCING AN INCREASE IN THE NUMBER OF SEIZURES. THE VNS DEVICE SETTINGS WERE INCREASED AT THIS VISIT. IT IS UNKNOWN WHETHER OR NOT THE INCREASE WAS ABOVE THE PATIENT'S PRE-VNS BASELINE FREQUENCY. CLINIC NOTES DATED (B)(6), 2012 INDICATED THAT THE PATIENT'S SEIZURES HAD RETURNED BACK TO BASELINE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 2401

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other