BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 101

    MDR report key: 1739603 · Received June 24, 2010

    Report

    Report Number
    1644487-2010-01486
    Event Type
    Injury
    Date Received
    June 24, 2010
    Date of Event
    April 27, 2010
    Report Date
    May 25, 2010
    Manufacturer
    CYBERONICS INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CLINIC NOTES FOR THIS PT WERE RECEIVED WHICH DOCUMENTED A NEW SEIZURE TYPE OF AN UNSPECIFIED CAUSE. THERE WAS NOTE THAT THERE WAS SUSPICION OF PSYCHOGENIC NON-EPILEPTIC SEIZURES (PNES), HOWEVER, THE PHYSICIAN REQUESTED AN AMBULATORY EEG BE PERFORMED AS SOON AS POSSIBLE IN ORDER TO CHARACTERIZE THE SEIZURE TYPE. IT WAS NOTED THAT THE PT WAS SCHEDULED FOR GENERATOR REPLACEMENT SURGERY, WHICH TOOK PLACE ON MAY 27TH TO PROPHYLACTICALLY REPLACE THE DEVICE. THE EXPLANTED GENERATOR HAS BEEN RETURNED TO MFR WHERE ANALYSIS IS UNDERWAY. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO REGARDING THE NEW SEIZURE TYPE AND THE BELIEVED RELATIONSHIP TO VNS THERAPY HAVE BEEN MADE, BUT NO ADDITIONAL INFO HAS BEEN RECEIVED TO DATE. DIAGNOSTIC TESTING DONE ONE MONTH PRIOR TO THE REPORT OF THE NEW SEIZURE TYPE REVEALED NORMAL DEVICE FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 101 LYJ CYBERONICS INC. 101 7090

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other