BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3485651 · Received November 25, 2013

    Report

    Report Number
    1644487-2013-03592
    Event Type
    Injury
    Date Received
    November 25, 2013
    Date of Event
    July 1, 2013
    Report Date
    November 1, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT HAS BEEN HAVING SOME STOMACH ISSUES SINCE (B)(6) 2013. THE PATIENT WAS REFERRED TO A GI DOCTOR AND SAID SHE MAY HAVE GASTROPARESIS. THE PATIENT CANNOT EAT BUT ABOUT 2 TSP. AT ONE TIME AND SOMETIMES EVENT THAT DOESN¿T STAY DOWN. THE PHYSICIAN DREW LABS LAST WEEK AND ON THE SECOND LAB DRAW HER PHENOBARB LEVEL WAS 57.4. THE PHYSICIAN THEREFORE TOLD HER TO DECREASE PHENOBARB TO 32.4MG 2XBID FROM 3XBID AND THE VIMPAT WAS DECREASED FROM 100MG TID TO 100BID AT HER (B)(6) 2013 VISIT. SINCE THE DROP IN PHENOBARB, SHE IS HAVING SOME BREAKTHROUGH SMALL SEIZURES. THE PATIENT¿S GI SYMPTOMS WERE HAPPENING BEFORE THE VNS INCREASE ON (B)(6) 2013, BUT HAVE WORSENED SINCE THEN; HOWEVER IT WAS NOTED THAT THIS COULD JUST BE PROGRESSING OF THE GASTROPARESIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    THE PHYSICIAN INDICATED THAT THE PRESENCE OF THE VNS MAY BE CAUSE THE PATIENT'S GI PROBLEMS AT HIGHER SETTINGS. IT WAS REPORTED THAT THE SYMPTOMS ARE BETTER ON LOWER SETTINGS. THE PHYSICIAN REPORTED THAT VNS OUTPUT CURRENT WAS NEVER ABOVE 1.5MA. THE DEVICE OUTPUT CURRENT WAS DECREASED TO 1.0MA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611358 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 202502

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other