BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2912010 · Received January 11, 2013

    Report

    Report Number
    1644487-2013-00136
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    January 1, 2012
    Report Date
    December 13, 2012
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: CORRECTED DATA: THE INITIAL REPORT STATED A SPECIFIC DATE FOR THE EVENT BUT IT IS UNKNOWN WHEN SPECIFICALLY THE INCREASE IN SEIZURE OCCURRED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS HAVING AN INCREASE IN SEIZURES UNKNOWN IF ABOVE OR BELOW BASELINE. THE PATIENT HAD PREVIOUSLY BEEN HAVING A SEIZURE EVERY SEVERAL WEEKS WITH VNS BUT WITH THE INCREASE WAS HAVING UP TO 5-6 SEIZURES A DAY. THE PHYSICIAN SAID THE INCREASE IN SEIZURE IS DUE TO LOW BATTERY BUT IT IS UNCLEAR IF THE SEIZURE ARE DUE TO THE BATTERY BEING AT END OF SERVICE OR IF THE PHYSICIAN FEELS THAT PATIENT'S BATTERY WAS LOW DUE TO THE INCREASE IN SEIZURES. THE PATIENT HAD A GENERATOR REPLACEMENT. GOOD FAITH ATTEMPTS FOR PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE. GOOD FAITH ATTEMPTS FOR MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE GENERATOR US NOT AVAILABLE FOR RETURNED TO THE MANUFACTURER FOR EVALUATION. THE HOSPITAL DOES NOT HAVE THE EXPLANTED GENERATOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE INCREASE IN SEIZURES WERE BELIEVED TO BE RELATED TO THE GENERATOR BEING DEPLETED. A BATTERY LIFE CALCULATION WAS PERFORMED WHICH INDICATED THAT THE GENERATOR WAS AT END OF SERVICE. THE INCREASE IN SEIZURES WAS BELOW PRE-VNS BASELINE. THERE WERE NO CONTRIBUTORY PROGRAMMING CHANGES, MEDICATION CHANGES, OR OTHER EXTERNAL FACTORS PRECEDE THE ONSET OF THE INCREASE IN SEIZURES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT¿S GENERATOR WAS UNABLE TO BE COMMUNICATED WITH ON (B)(6) 2012 BELIEVED TO BE DUE TO END OF SERVICE. THE PATIENT SAID THE SEIZURE BEGAN INCREASING 4-6 WEEKS PRIOR TO THE (B)(6) 2012 APPOINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16780 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 201201

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention