BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 102

    MDR report key: 2083052 · Received May 5, 2011

    Report

    Report Number
    1644487-2011-01005
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 14, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY A NEUROLOGIST THAT A VNS PT WAS BEING REFERRED FOR SURGERY DUE TO END OF SERVICE (EOS). THE PT WAS REFERRED TO SURGEON WHOM FOUND THE DEVICE WAS NOT AT EOS. THE PT WAS AVERAGING ONE TO TWO SEIZURES PER DAY WHICH WAS LESS THAN HIS HISTORY OF FIVE TO SIX PER DAY. THE PT'S FAMILY REPORTED THAT PT'S SEIZURES HAD PROGRESSIVELY GOTTEN WORSE. SO, THE TREATING NEUROLOGIST ADJUSTED HIS VNS PROGRAMMING SETTINGS TO 3/20/250/60/0.3 AND MAGNET SETTINGS 3.25/500/60. THIS ADJUSTMENT STILL DID NOT BRING PT SEIZURES UNDER CONTROL. MFR RECEIVED ADD'L INFO IN FORM OF CLINIC NOTES THAT ON (B)(6) 2011, PT WAS SEEN BY THE NEUROLOGIST AND THE PT WAS HAVING MORE BREAKTHROUGH SEIZURES ABOVE PRE-VNS BASELINE. THE MAGNET SWIPE ALSO DID NOT HAVE ANY RELIEF OF CLINIC RESPONSE BUT CAUSING HEADACHE AND PAIN IN THE NECK AREA WHICH WAS RELATED TO VNS STIMULATION. THERE WAS NO REPORT OF TRAUMA OR MANIPULATION TO THE VNS DEVICE. THE PROGRAMMING SETTINGS WERE MODIFIED AGAIN TO 3/25/500/0.3/60 AND MAGNET MODE 3.25/500/60. THE PT'S MEDICATIONS WERE ALSO ADJUSTED TO ADDRESS THE POOR SEIZURE CONTROL. PER THE PHYSICIAN, THE PT WAS RECEIVING 65% EFFICACY PRIOR TO INCREASE SEIZURE. ON (B)(6) 2011, THE PHYSICIAN FOUND THAT THE VNS DEVICE WAS SHOWING EOS. A REVISION SURGERY IS LIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 102 LYJ CYBERONICS, INC. 102 200961

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention