BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2832906 · Received November 14, 2012

    Report

    Report Number
    1644487-2012-03005
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 7, 2012
    Report Date
    October 15, 2012
    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

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINIC NOTES RECEIVED DATED (B)(6) 2012 THAT THE VNS PATIENT EXPERIENCED FOUR SEIZURES FOUR DAYS PRIOR TO THE REPORT. ONE OF THE SEIZURES WAS A GENERAL TONIC-CLONIC SEIZURE LASTING 1.5 MINUTES. THE PATIENT NORMALLY EXPERIENCES 1-2 SEIZURES PER WEEK WITH VNS. VNS DIAGNOSTICS TAKEN AT THE OFFICE VISIT WERE WITHIN NORMAL LIMITS. THE PHYSICIAN INDICATED THAT THERE HAVE BEEN MANY RECENT DOSE ADJUSTMENTS OF THE PATIENT'S LAMICTAL AND CELONTIN "CAUSING VARIABLE MED LEVELS AND VARIABLE SEIZURE CONTROL." THE PATIENT WAS ADMITTED TO THE HOSPITAL AT WHICH TIME IT WAS NOTED THAT THE PATIENT'S LAMOTRIGINE LEVEL WAS HIGH. THE VNS SETTINGS WERE NOT CHANGED HOWEVER THE PATIENT WAS REFERRED FOR VNS GENERATOR REPLACEMENT AS THE GENERATOR WAS BELIEVED TO BE NEAR END OF SERVICE. A BATTERY LIFE CALCULATION ESTIMATES THE GENERATOR IS LIKELY AT, NEAR, OR PAST END OF SERVICE. SURGERY TO REPLACE THE PATIENT'S GENERATOR HAS OCCURRED. ATTEMPTS FOR THE RETURN OF THE EXPLANTED GENERATOR WERE UNSUCCESSFUL AS THE SITE INDICATED THEY WILL NOT RETURN EXPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 016932

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention