• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medsun Reports

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Back to search results
Type of Device:
stimulator, autonomic nerve, implanted for epilepsy - lead
stimulator, autonomic nerve, implanted for epilepsy
Device Brand Name:
VNS Pulse
Device Manufacturer's Name:
Cyberonics Inc.
Date of this Report:
Describe the Event
or Problem:
Patient who had vagal nerve stimulator implanted ~3 years ago (pt had history of intractable epilepsy). He subsequently moved to out of state and reports establishing care at a neurology practice, and a physician there changed settings as the device was affecting his voice. After that time, he began to have difficulties which retrospectively he feels were related to his device. He was an avid runner, and would experience shortness of breath when he would run after about 5 minutes, and would then improve after he would stop for a few minutes. At the time he attributed it to the change of climate. He eventually developed severe shortness of breath and it was found that his stimulator was misfiring causing constriction of the vocal cords. After that time, the device was turned off and it subsequently has been off ever since. The patient returned for removal of the stimulator. The lead remains in the patient.
the device(s) may have
caused or contributed to:
Potential for patient harm
New Search