BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3853131 · Received June 6, 2014

    Report

    Report Number
    1644487-2014-01416
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    January 1, 2007
    Report Date
    May 7, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS INADVERTENTLY REPORTED INCORRECTLY IN INITIAL MFR REPORT.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2008, IT WAS NOTED THAT THE PATIENT EXPERIENCED SEVERAL SEIZURES IN (B)(6) 2008. IT WAS NOTED THAT IN (B)(6) 2008, THE PATIENT EXPERIENCED THREE GRAND MAL SEIZURES AND TWO IN (B)(6) 2008. CLINIC NOTES DATED (B)(6) 2007 NOTED THAT THE PATIENT'S CAREGIVER WAS CONCERNED BECAUSE THE PATIENT HAD BEEN HAVING MANY SEIZURES SINCE THE PREVIOUS VISIT. THE PATIENT'S SETTINGS WERE INCREASED FROM 0.75 MA TO 1.0 MA OUTPUT CURRENT. THE PATIENT'S CURRENT TREATING PHYSICIAN INDICATED THAT IT IS UNKNOWN IF THE SEIZURES WERE ABOVE THE PATIENT'S PRE-VNS BASELINE FREQUENCY SINCE THIS OCCURRED, SO LONG AGO AND HE DOES NOT HAVE ALL OF THE DETAILS. IT WAS REPORTED THAT THE PATIENT HAS SAID THAT HER SEIZURES IN GENERAL ARE BETTER WITH VNS. NO ADDITIONAL RELEVANT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332894 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 014460

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention