Cl Il Cyberonics VNS Therapy Demipulse Generator

Company:Cyberonics, Inc.
Date of Enforcement Report 12/9/2009
Class:ll

PRODUCT
Cyberonics VNS Therapy Demipulse Generator Model 250 Programming System, version 4.6, 6.1, 7.0, and 7.1 labeling, for vagus nerve stimulation. Recall # Z-0264-2010

REASON
Failure to deliver therapy. Some VNS Therapy System replacement Demipulse generators reporting low lead impedance readings. In rare instances, a system diagnostic test using Model 250 Programming Software (versions 7.1 and earlier) may report “Lead Impedance: OK” when a short-circuit condition exists that prevents the lead from delivering therapy to the vagus nerve.

RECALLING FIRM/MANUFACTURER
Cyberonics, Inc., Houston, TX, by letter on July 24, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
9,500 programming devices

DISTRIBUTION
Nationwide, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Poland, Portugal, Puerto Rico (US Territory), Russia, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.