BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 3181543 · Received June 21, 2013

    Report

    Report Number
    1644487-2013-01868
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 18, 2013
    Report Date
    May 23, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT THE RELATIONSHIP TO VNS THERAPY IS NOT RELATED TO THE INCREASE IN SEIZURES. THERE WAS NO PATIENT MANIPULATION OR TRAUMA THAT IS BELIEVED TO HAVE CAUSED THE INCREASED SEIZURES. IT WAS REPORTED THAT THE DEVICE WAS INTERROGATED AND WAS FUNCTIONING PROPERLY AND THAT THE PATIENT'S MEDICATIONS WERE INCREASED. THE INCREASE IN SEIZURES WAS AT PRE-VNS BASELINE FREQUENCY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT'S HUSBAND REPORTED THAT HE BELIEVES THE PATIENT'S DEVICE IS NOT WORKING. HE EXPLAINED THAT THE PATIENT HAS BEEN HAVING A LOT OF SEIZURES SINCE (B)(6) 2013, AND THAT SHE WAS CURRENTLY IN THE EMERGENCY ROOM. HE FURTHER STATED THAT THE DEVICE DOES NOT SEEM TO COME ON WHEN HE SWIPES THE MAGNET, AS HE IS NOT ABLE TO FEEL THE VIBRATION HE NORMALLY DOES AFTER THE SWIPE, AND BECAUSE THE SWIPES ARE NOT STOPPING THE SEIZURES LIKE THEY USED TO. NO OTHER INFORMATION WAS PROVIDED. ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION; HOWEVER, THEY WERE UNSUCCESSFUL. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A REVIEW OF THE PATIENT'S PROGRAMMING HISTORY FOUND DIAGNOSTIC DATA FROM (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283566 PULSE GEN MODEL 102 GENERATOR LYJ CYBERONICS, INC. 102 016943

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other