• 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:
Cyberonics VNS Pulse Generator
Device Brand Name:
Demipulse
Device Manufacturer's Name:
Cyberonics
Date of this Report:
(mm/dd/yyyy)
03/08/2011
Describe the Event
or Problem:
Explantation of Cyberonics VNS Demipulse model 103 from left upper anterior chest due to malfunction. Patient reported shock-like sensation on the site extending up to the neck and down to left arm and left upper abdomen. Patient did not experience permanent harm.
the device(s) may have
caused or contributed to:
Minor injury to the patient or health care provider
New Search
-
-