BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 1983036 · Received February 7, 2011

    Report

    Report Number
    1644487-2011-00207
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    October 1, 2010
    Report Date
    January 11, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM, CORRECTED DATA: THE INITIAL REPORT INADVERTENTLY REPORTED THE INTERVENTION REGARDING CHANGE IN MEDICATION INCORRECTLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD GENERATOR REPLACEMENT ON (B)(6) 2011. THE GENERATOR WAS DISCARDED BY THE EXPLANT HOSPITAL. THEREFORE, ANALYSIS IS UNABLE TO BE PERFORMED. INTERVENTIONS TAKEN WERE TO DECREASE ON OF THE PATIENT¿S ANTI-EPILEPTIC MEDICATION DOSAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH CLINIC NOTES DATED (B)(6) 2010 THAT A VNS PATIENT EXPERIENCED AN UNEXPECTED INCREASE IN FREQUENCY OF SEIZURES. PREVIOUSLY, THE PATIENT HAD ABOUT 7-8 SZ/MONTH WHICH WAS 2 YRS AGO. HER SEIZURES THEN DECREASED TO ABOUT 3-4/MO, AND THEN DECREASED TO 1-2. HOWEVER, IN THE MONTH OF (B)(6), PATIENT HAD 2 SEIZURES AND IT IS UNCLEAR IF THEY WERE EPILEPTIC. THE PATIENT, OVER THE COURSE OF (B)(4) HAD 3-4 SEIZURES. INTERVENTIONS TAKEN WERE TO INCREASE THE PATIENT'S AEDS. THE PATIENT HAS BEEN UNDER A LOT OF STRESS AND STRESS IS ONE OF THE TRIGGERS FOR EPILEPTIC SEIZURES. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 013315

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention