BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2100474 · Received May 13, 2011

    Report

    Report Number
    1644487-2011-01046
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A PHYSICIAN THAT THE PATIENT CAME INTO THE OFFICE STATING THAT HE HAD AN INCREASE IN SEIZURES. THE FREQUENCY OF THE SEIZURE ACTIVITY WAS NOT KNOWN, BUT HE ALSO HAD SOME "WARMTH" IN HIS NECK THAT OCCURRED "EVERY ONCE IN A WHILE", WHICH HAD BEEN OCCURRING FOR APPROXIMATELY SIX MONTHS. ALL DIAGNOSTIC TESTING WAS REPORTEDLY WITHIN NORMAL LIMITS WITH DCDC=2 AND EOS=NO. THE PHYSICIAN WAS NO LONGER ABLE TO SEE THE PATIENT DUE TO INSURANCE ISSUES, BUT THE PATIENT WAS STATED TO BE NON-COMPLIANT WITH HIS MEDICATIONS AND FOLLOW-UP VISITS. FOLLOW-UP FROM THE PHYSICIAN INDICATED THAT THE SYMPTOMS IN THE PATIENT'S NECK MAY BE RELATED TO VNS, BUT IT WAS UNCLEAR IF THE CHANGE IN SEIZURES WAS. ALSO, IT APPEARED THAT A BATTERY REPLACEMENT SURGERY WAS SUGGESTED TO THE PATIENT, BUT DUE TO COVERAGE ISSUES THIS WAS UNABLE TO BE PERFORMED. FURTHERMORE, THE OFFICE STATED THAT THE FREQUENCY OF THE SEIZURES WAS UNKNOWN AS THE PATIENT HAD ISSUES WITH NON-COMPLIANCE. ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS, INC. 101 4678

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other