BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2973796 · Received February 22, 2013

    Report

    Report Number
    1644487-2013-00481
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    April 1, 2012
    Report Date
    January 25, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2012 REPORTED THAT THE VNS PATIENT'S MOTHER STATED THAT THERE WERE SOME CHANGES IN THE PAST 6-8 MONTHS. MOM STATED THAT HE STATED TO HAVE GRAND MAL SEIZURES AGAIN AFTER HE STARTED TO HAVE REM SLEEP. MOM IS NOT SURE HOW OFTEN HE IS HAVING A GRAND MAL SEIZURE. HE WILL HAVE THE SEIZURE FOR 2 MINUTES AND THEN THE BODY WILL RELAX AND THEN HE WILL GO BACK INTO ANOTHER SEIZURE 2-3 TIMES. PATIENT WILL ALSO HAVE DROP ATTACKS AT THE NURSING HOME WHERE HE WILL FALL AND HURT HIMSELF WHICH WILL LAST A COUPLE OF SECONDS AND THEN HE IS UP AGAIN. MOM HAS NOTICED WHEN HE HAS A SEIZURE HIS BLOOD SUGAR WILL BE ELEVATED. SHE STATES THAT THE BLOOD SUGAR IS GETTING HARDER TO KEEP UNDER CONTROL. THE PHYSICIAN'S ASSISTANT DICTATED THAT THE VNS DOES NOT REALLY SEEM TO HELP. THE RELATIONSHIP OF THE INCREASED SEIZURES TO VNS IS UNCLEAR. THE PATIENT'S TWO ANTI-SEIZURE MEDICATIONS WERE REPORTED TO NOT BE KEEPING THE PATIENT UNDER CONTROL AT THAT TIME. NO INTERVENTIONS WERE NOTED. GOOD FAITH ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77781 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS INC 102 6559

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR