BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3192841 · Received June 27, 2013

    Report

    Report Number
    1644487-2013-01947
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 28, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT ON (B)(6) 2013. THE GENERATOR WAS RETURNED FOR ANALYSIS ON (B)(4) 2013. ANALYSIS OF THE GENERATOR WAS COMPLETED ON (B)(4) 2013. IN THE PA LAB, THE DEVICE OUTPUT SIGNAL WAS MONITORED FOR MORE THAN 24-HRS, WHILE THE GENERATOR WAS PLACED IN A SIMULATED BODY TEMPERATURE ENVIRONMENT. RESULTS SHOWED NO SIGNS OF VARIATION IN THE PULSE GENERATOR¿S OUTPUT SIGNAL AND DEMONSTRATED THAT THE DEVICE PROVIDED THE EXPECTED LEVEL OF OUTPUT CURRENT FOR THE ENTIRE MONITORING PERIOD. THE PULSE GENERATOR DIAGNOSTICS WERE AS EXPECTED FOR THE PROGRAMMED PARAMETERS. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS IN THE PA LAB CONCLUDED PROPER FUNCTIONALITY OF THE PULSE GENERATOR AND THAT NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND.

    Description of Event or Problem · 1

    CLINIC NOTES DATED (B)(6) 2013 WERE RECEIVED WHICH PROVIDE THE PATIENT'S SEIZURE HISTORY. IT WAS STATED THAT THE PATIENT IS STILL HAVING SEIZURES DAILY. THE PATIENT'S LAST SEIZURE WAS A GRAND MAL SEIZURE THAT LASTED 2 MINUTES THAT DAY, AND PRIOR TO THIS WAS THE SAME TYPE AND LENGTH OF SEIZURE ON (B)(6) 2013. THE PATIENT HAS CONTINUED WITH NOCTURNAL EVENTS SEMIOLOGY OF COMPLEX PARTIAL SEIZURES PER HIS BASELINE. HE BEGAN HAVING DAILY EPISODE OF QUICK HEAD DROPS ABOUT ONE WEEK PRIOR TO THIS DATE. HIS MOTHER NOTED DRAINAGE FROM HIS LEFT EAR AND HAD SCHEDULED A FOLLOW UP APPOINTMENT TO THE EAR NOSE THROAT DOCTOR. IT WAS NOTED THAT PRIOR EAR INFECTIONS HAVE BEEN A TRIGGER FOR THE PATIENT'S EPILEPSY AND MCAD RELATED HYPOGLYCEMIA. FOLLOWING A NEURO METABOLIC CONSULT, GENETIC TESTING CONFIRMED THE PATIENT HAD MCAD. FOLLOWING THE INTRODUCTION OF BANZEL, THE PATIENT BECAME SEIZURE FREE WITH ASSOCIATED IMPROVED COGNITION AND PSYCHOMOTOR ACTIVATION. DROP SEIZURES RETURNED IN CLUSTERS WITH RECURRENT EAR INFECTIONS. THEY CONTINUED TO INCREASE IN THEIR DAILY FREQUENCY TO GREATER THAN ONE HUNDRED PER DAY DESPITE INCREASING DOSES OF BANZEL AND INCREASED USE OF BENZOS. IN ADDITION, THEY WERE LESS RESPONSIVE TO USE OF THE VNS MAGNET. HOWEVER, THE NOTES ALSO MENTION THAT THE PATIENT'S MOTHER WAS OBSERVED TO BE USING THE MAGNET INCORRECTLY AND WAS INSTRUCTED ON THE CORRECT USE OF THE MAGNET DURING THIS OFFICE VISIT. THE PATIENT IS EXPERIENCING NIGHTIME SEIZURES WHICH RESOLVED WITH THE ADDITION OF BANZEL; HOWEVER, IT WAS STATED THAT IT WAS UNCLEAR WHEN THEY BEGAN TO REOCCUR NIGHTLY. DURING THE PATIENT'S LAST VISIT, THE PATIENT'S LACK OF CONSCIOUSNESS AND MULTIPLE DROP ATTACKS OF UNCLEAR ETIOLOGY WERE NOTED RESULTING IN PATIENT HOSPITALIZATION. DURING HOSPITALIZATION, INCREASED AMMONIA WAS NOTED. IN ADDITION, THE PATIENT WAS MARKEDLY RESPONSIVE TO IV, CONCLUDING THAT HIS PRESENTING STATE WAS METABOLIC RELATED. THE PATIENT'S MEDICATION WAS INCREASED AND THE EEG WAS CONCLUSIVE FOR NON-EPILEPTIC AS WELL AS EPILEPTIC EVENTS. AT FOLLOW UP, THE PATIENT'S COGNITION WAS MARKEDLY IMPROVED OVER PRIOR VISITS. IN REGARDS TO THE DAILY EPISODES OF QUICK HEAD DROPS THAT STARTED A WEEK PRIOR, WHICH HAD THE SEMIOLOGY OF NON-EPILEPTIC EVENTS ASSOCIATED WITH HYPOGLYCEMIA AND INCREASED METABOLIC NEEDS. ATTEMPTS FOR ADDITIONAL INFORMATION WERE MADE; HOWEVER, THEY WERE UNSUCCESSFUL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294096 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 016318

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other