BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2851362 · Received November 29, 2012

    Report

    Report Number
    1644487-2012-03135
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    August 1, 2012
    Report Date
    October 31, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN; HOWEVER THE SPECIFIC QUESTIONS IN REGARDS TO THE BREAKTHROUGH SEIZURES IN (B)(6) WERE NOT ADDRESSED. THE PHYSICIAN DECLINED TO GIVE FURTHER INFORMATION ON THESE EVENTS. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN WHICH INDICATES THAT THE PERIODIC INCREASE IN SEIZURES EXPERIENCED AFTER VNS REPLACEMENT (REPORTED IN MANUFACTURER REPORT NUMBER 1644487-2013-00325) IS NOT RELATED TO VNS AND IS, IN FACT, RELATED TO THE ONES PRIOR TO BATTERY REPLACEMENT. IT WAS ADDITIONALLY STATED THAT THESE SEIZURES REFER TO THE SAME DAILY MORE INTENSE SEIZURES THAT OCCURRED IN NOVEMBER AFTER THE SETTINGS CHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH CLINIC NOTES DATED (B)(6), 2012 THAT THE PATIENT HAD EXPERIENCED A BREAKTHROUGH IN SEIZURES IN (B)(6) 2012. AS THE EXACT DATE THE BREAKTHROUGH IN SEIZURES OCCURRED IS UNKNOWN, THE DATE (B)(6) 2012 HAS BEEN USED AS THE EVENT DATE. IT IS UNKNOWN WHAT THE RELATIONSHIP IS BETWEEN THE BREAKTHROUGH IN SEIZURES AND VNS AND WHAT THE INCREASED SEIZURE FREQUENCY WAS IN COMPARISON TO PRE-VNS BASELINE LEVELS. THE PATIENT'S BLOOD LEVELS WERE CHECKED IN RESPONSE, AND ALL CHEMISTRIES WERE NORMAL WITH THE EXCEPTION OF BILLRUBIN THAT WAS LOW AND A LOW HEMOGLOBIN COUNT WHICH SUGGESTED THE NEED FOR IRON SUPPLEMENTATION. IT IS UNKNOWN IF ANY OTHER INTERVENTIONS WERE TAKEN. CURRENTLY THE PATIENT IS DOING VERY WELL WITH SEIZURE CONTROL. PER THE NOTES, THE PATIENT WENT TWELVE DAYS WITHOUT A SINGLE SEIZURE, WHICH THE PHYSICIAN WAS PLEASED WITH. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 2709

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other