BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3790885 · Received May 5, 2014

    Report

    Report Number
    1644487-2014-01197
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO BELIEVED STATUS EPILIEPTICUS. IT WAS REPORTED THAT THE PATIENT WOULD BE HOSPITALIZED FOR A FEW MORE WEEKS. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT DEVICE DIAGNOSTICS ARE "OK". THE PHYSICIAN REPORTED THAT THE QUESTION HAS BEEN RAISED ON IF VNS EXACERBATES SEIZURES. THE PATIENT HAS BEEN EXPERIENCING RECURRENT CLUSTERS OF SEIZURES OR STATUS EPILEPTICUS. THE PHYSICIAN INDICATED THAT THIS LED THE PATIENT TO BE HOSPITALIZED FOUR TIMES IN THE FIRST SIX MONTHS OF 2014. THE PHYSICIAN REPORTED THAT SOME OF THESE EVENTS APPEAR TO BE CLEARLY RELATED WITH SYSTEM INFECTION AND SEPSIS ASSOCIATED WITH PRESUMED UTI OR (B)(6). IT WAS ALSO REPORTED THAT THE PATIENT HAD A FEW MORE EMERGENCY DEPARTMENT VISITS FOR RECURRENT CLUSTER SEIZURES. THE PHYSICIAN REPORTED THAT THE VNS WAS PROGRAMMED OFF ON (B)(6) 2014, AFTER STARTING REDUCED INTENSITY OF 0.75MA ON (B)(6) 2014. THE PHYSICIAN INDICATED THAT THE PATIENT'S LAST SEIZURE WAS ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266463 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 3145

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| O