BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 6072085 · Received November 2, 2016

    Report

    Report Number
    1644487-2016-02543
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    June 6, 2016
    Report Date
    October 10, 2016
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT HAS HAD HIS DEVICE SWITCHED OFF.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT WAS SEEN FOR INVESTIGATION INTO FEEDING PROBLEMS DUE TO REFLUX BUT ONLY IN THE PAST 8 MONTHS. MUM DOES NOT LIKE SOMETHING BEING IN HIS BODY AND WANTS IT OUT ANYWAY. WHEN NURSE HAVE SEEN PATIENT IN CLINIC THERE WAS NO COUGHING OR VOMITING; NURSE ONLY MET PATIENT ON (B)(6) 2016 SO HAVE NO INFORMATION PRIOR WITH REGARD TO THE VNS. VNS PARAMETERS HAVE BEEN CHANGED. THE MAGNET ON TIME AND WIDTH WAS CHANGED ON (B)(6) 2016 BECAUSE WHILST HE WAS AN INPATIENT MUM SAID THAT EVERY TIME SHE USED THE MAGNET PATIENT STARTED TO COUGH. THEY THEN TRIED 30/250 AND AFTER A COUPLE OF DAYS THIS SETTLED. ON (B)(6) 2016 THE SIGNAL OFF TIME WAS CHANGE TO 3 MINUTES INITIALLY THEN AFTER OR HOUR OR SO CHANGED TO 1.8. THIS WAS FOLLOWING DISCUSSIONS WITH MUM AND BASED ON SEIZURE BURDEN (2-3 TONIC/CLONIC PER DAY). PATIENT SEEN IN CLINIC ON (B)(6) 2016 AND NO CHANGER TO SEIZURES BUT MUM STILL SAID HE WAS COUGHING AND VOMITING THROUGHOUT THE DAY. HOWEVER, THERE WERE INCONSISTENCIES IN MUM'S EXPLANATIONS AND TIME OF COUGHING/VOMITING. THE PHYSICIANS DON'T THINK IT IS RELATED TO THE VNS BUT RATHER LONG TERM PROBLEMS WITH FEEDING ISSUES (NOT TOLERATING/POSSIBLE TYPES OF FEEDS NOT SUITING PATIENT).

    Description of Event or Problem · 1

    IT WAS REPORTED BY PARENTS THAT VNS PATIENT HAS BEEN COUGHING THEN VOMITING MORE OR LESS CONSTANTLY SINCE INSERTION OF THE VNS SYSTEM. IT WAS REPORTED THAT THE FIRST YEAR, PATIENT WAS OK, UNTIL RECENTLY WHEN PATIENT WAS SEEN DUE TO FEEDING PROBLEMS AND VOMITING BUT THE PEDIATRICIAN DID NOT THINK IT WAS RELATED. IT WAS REPORTED THAT THE NURSE CHANGED SOME PARAMETERS AND HAD TO ADJUST THE MAGNET BECAUSE OF PATIENT COUGHING WHEN MAGNET SWIPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725015 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR