BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 2201796 · Received August 5, 2011

    Report

    Report Number
    1644487-2011-01801
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    January 1, 2005
    Report Date
    July 7, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: IT WAS INADVERTENTLY REPORTED PREVIOUSLY THAT THE SEIZURES BEGAN IN 2006, BUT THEY ACTUALLY APPEAR TO HAVE BEGUN SOMETIME IN 2005. CORRECTION: THE SEIZURES PREVIOUSLY MENTIONED IN 2011 ARE NOT APPLICABLE TO THIS EVENT AS THEY OCCURRED WITH A DIFFERENT GENERATOR AND WERE REPORTED UNDER MEDWATCH #1644487-2011-01619.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINIC NOTES, THAT THE PT HAD EXPERIENCED SEVERAL INCREASES IN SEIZURES OVER THE PAST FEW YEARS AND PAIN WITH STIMULATION. THE PT'S OUTPUT CURRENT WAS DECREASED TO 2.75 MA. IT WAS ALSO NOTED THAT THE PT HAD SURGERY FOR EXCISION OF AN ACOUSTIC NEUROMA AND SOME OF THE SEIZURES BEGAN AFTER THIS SURGERY IN 2011. IT WAS ALSO NOTED THAT MANY OF THE SEIZURES APPEAR TO BE CAUSED BY STRESS AND CANNOT BE CONTROLLED WITH VNS OR MEDICATIONS. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    IT WAS INADVERTENTLY REPORTED PREVIOUSLY THAT THE SEIZURES BEGAN IN 2006, BUT THEY ACTUALLY APPEAR TO HAVE BEGUN SOMETIME IN 2005 PER CLINIC NOTES. ALSO, THE SEIZURES PREVIOUSLY MENTIONED IN 2011 ARE NOT APPLICABLE TO THIS EVENT AS THEY OCCURRED WITH A DIFFERENT GENERATOR AND WERE REPORTED UNDER MEDWATCH #1644487-2011-01619.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS INC 101 1452

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention