Safety Notice for the VNS Therapy Demipulse and Demipulse Duo Generators, Cyberonics
2011.10.20
Product group Active implantable medical devices
Reference 02284/11
Important Field Safety Notice of Cyberonics Inc., Houston, Texas, USA, the manufacturer of implantable Vagus Nerve Stimulation Therapy Generators Demipulse Model 103 and Demipulse Duo Model 104, due to possible risk of earlier than expected or delayed indication of Intensified the Follow Up Indicator (IFI).