BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 2873421 · Received December 14, 2012

    Report

    Report Number
    1644487-2012-03342
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    May 24, 2012
    Report Date
    November 16, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION FROM CLINIC NOTES INADVERTENTLY NOT INCLUDED IN INITIAL MDR. RELEVANT TEST/LABORATORY DATA INCLUDING DATES, CORRECTED DATA: INFORMATION INADVERTENTLY NOT INCLUDED IN INITIAL MDR.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2012, INDICATE THAT THE PATIENT HAD AN INCREASE IN SEIZURES. PER THE PATIENT'S MOTHER, THE PATIENT WAS HAVING THREE TO FIVE SEIZURES PER WEEK AND THE MOTHER WAS NOT SATISFIED WITH THESE RESULTS. PER THE NOTES, HISTORICALLY, THE PATIENT NEVER HAD A SIGNIFICANT SEIZURE-FREE INTERVAL. THE PATIENT AND HIS FAMILY REPORT THREE SEIZURE TYPES. THE PATIENT HAS BRIEF EPISODES OF UNRESPONSIVE STARING LASTING UP TO TEN SECONDS AT A TIME WHICH OCCURS AS MANY AS TEN TIMES PER DAY. THE PATIENT HAS MYOCLONIC JERKS ON A DAILY BASIS ABOUT ONCE PER DAY USUALLY AT NIGHT OR IN THE EARLY MORNING HOURS. LASTLY THE PATIENT HAS REPETITIVE JERKING THAT PROGRESSES TO A TONIC-CLONIC SEIZURE THAT IS USUALLY BRIEF AND LASTS LESS THAN THIRTY SECONDS. WHILE IT IS REPORTED THAT THE MOTHER WAS NOT SATISFIED WITH THE SEIZURE CONTROL AT THIS TIME, IT WAS STATED THAT THE PATIENT WAS DOING ABOUT THE SAME SINCE HIS LAST VISIT. IT IS UNKNOWN WHAT TYPE OF SEIZURES THE THREE TO FIVE ARE WHICH WAS REPORTED OR WHAT THE RELATIONSHIP WAS TO PRE-VNS BASELINE LEVELS. THE PATIENT'S VNS SETTINGS WERE ADJUSTED TO RAPID CYCLING AND MEDICATION CHANGES WERE MADE. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2012 INDICATE THAT THE PATIENT'S SEIZURE FREQUENCY HAS DECREASED SINCE THE LAST VISIT AND THE PATIENT'S MOTHER IS SOMEWHAT SATISFIED WITH THE SEIZURE CONTROL. THE PATIENT IS HAVING TWO TO THREE TONIC CLONIC SEIZURES PER WEEK WITH CONTINUED MULTIPLE PARTIAL SEIZURES. IT WAS ALSO NOTED THAT THE PATIENT'S DEVICE WAS NOT NEAR END OF SERVICE. NOTES DATED (B)(6) 2012 INDICATE THAT THE PATIENT'S MEDICATION WAS CHANGED AT THE PREVIOUS VISIT AND THAT THE PATIENT'S FAMILY NOW REPORTS THAT EVERYTHING IS GOING WELL. IT WAS REPORTED THAT THE PATIENT'S SEIZURES WERE MUCH BETTER AND THAT THE FAMILY WAS SATISFIED WITH THE SEIZURE CONTROL. ADDITIONAL INFORMATION FROM THE PHYSICIAN'S NURSE FOUND THAT THE FORMER PHYSICIAN'S ASSISTANT WHO SAW THIS PATIENT WOULD ALWAYS NOTE IF THE PATIENT OR THE PATIENT'S FAMILY WAS SATISFIED WITH SEIZURE CONTROL; HOWEVER, THIS DID NOT INDICATE AN INCREASE IN SEIZURES. THE NURSE STATED THAT THE PATIENT WAS ALREADY IMPLANTED WITH THE DEVICE WHEN FIRST SEEN BY THE PHYSICIAN, SO THE RELATIONSHIP OF THE SEIZURES TO PRE-VNS LEVELS WAS UNKNOWN. PER THE NURSE, THE MEDICATION CHANGES DURING THIS TIME WERE NOT RELATED TO VNS AND THE PATIENT'S SEIZURE FREQUENCY WAS NOT RELATED TO VNS. THE NURSE STATED THAT THE PATIENT HAD INTRACTABLE SYMPTOMATIC GENERALIZED EPILEPSY WITH LYNX. NO OTHER INFORMATION WAS PROVIDED IN REGARDS TO THE SEIZURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 104 GENERATOR LYJ CYBERONICS, INC. 104 2190

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other