BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 104

    MDR report key: 2974890 · Received February 22, 2013

    Report

    Report Number
    1644487-2013-00489
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 24, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    A FAX WAS RETURNED FROM THE PHYSICIAN ASKING THE MANUFACTURER TO STOP CONTACTING HIM. HE DID NOT FEEL THAT THIS WAS A REPORTABLE EVENT AND DID NOT ADDRESS THE QUESTIONS. HE INDICATED THAT THE PATIENT'S GENERATOR WAS AT END OF SERVICE. IT IS POSSIBLE THE PATIENT'S SEIZURES WERE RELATED TO THE GENERATOR BEING AT END OF SERVICE. ON REVIEW OF THE MANUFACTURER'S PROGRAMMING HISTORY DATABASE THE GENERATOR HAS A IFI FLAG ON 10/03/2013.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD AN INCREASE IN SEIZURE NUMBER AND INTENSITY. SHE TYPICALLY HAD A SEIZURE IN THE MORNING ALMOST EVERY MORNING IS A HAVING AT LEAST TWO SEIZURES WHICH ARE MORE SEVERE. THIS HAS BEEN MORE NOTICEABLE SINCE THE END OF DECEMBER. THE PATIENT GENERATOR HAS THE IFI FLAG TRIGGERED BUT IS US STILL ABLE TO DELIVER THE PROGRAMED THERAPY. THE PATIENT HAS HAD A GENERATOR REPLACEMENT. GOOD FAITH ATTEMPTS FOR MORE INFORMATION AND PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78880 PULSE GEN MODEL 104 GENERATOR LYJ CYBERONICS, INC. 104 2701

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention