BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3052305 · Received April 11, 2013

    Report

    Report Number
    1644487-2013-00984
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    January 25, 2012
    Report Date
    March 12, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE - IMPLANT DATE - CORRECTED DATA: IMPLANT DATE CORRECTED.

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED FOR REVIEW IN RELATION TO THIS PATIENT'S GENERATOR BEING NEAR END OF BATTERY LIFE. IN REVIEW IT WAS NOTED THAT ON (B)(6) 2013 "SHE REPORTS 2 EPISODES A MONTH, ONE EPISODE IS IN THE LAST WEEK OF THE MONTH, WHICH IS LIKE AN AURA, WHICH SHE DESCRIBES AS NOT BEING IN CONTROL." IT WAS NOTED ON (B)(6) 2012 THAT THE PATIENT REPORTS EPISODES OF THOUGHT DISTURBANCES, WHICH SHE REPORTS AS A FEELING OF HAVING A SEIZURE. SHE SAYS SHE HEARS THAT SOMETHING MAY HAPPEN IN HER MIND. THIS USUALLY HAPPENS AT THE END OF THE MONTH. SHE REPORTS THAT SHE HAD A BLACK OUT SPELL AT THE FIRST OF THE WEEK. A BLACK OUT MEANS THAT SHE LOSES CONSCIOUSNESS, SHE RECALLS LOSING THE CONSCIOUSNESS, THOUGH DOESN'T RECALL ANYTHING ELSE. SHE LIVES ALONE AND THESE EVENTS ARE NOT WITNESSED. GOOD FAITH ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN ATTAINED. RELATIONSHIP OF THIS BLACK OUT SPELL TO THEIR VNS IS UNKNOWN. UNKNOWN IF PART OF THE PATIENT'S USUAL SEIZURE PATTERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156988 PULSE GEN MODEL 102 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 015709

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other