Safety Alert letters listed below are no longer active, but are being provided to the reader on important safety information about the VNS Therapy system. This information should be used as supplemental information and therefore physicians should be familiar with the contents of these letters.
Safety Alert, Demipulse Inaccurate Battery Longevity Projection
VNS Therapy Model 250 Programming System Low Impedance measurements.
EOS Indicator Use of Electrocautery or Exposure to Static Electricity Surgeon Letter
DemiPulse EOS Indicator Following Physician
Generator reset events on VNS Therapy™Demipulse/Demipulse Duo Generators (Model 103 and Model 104) for generators sold before April 15, 2008.
Lead strain relief configuration on VNS Therapy Lead™ Model 302 and the VNS Therapy Perennia Lead™ Model 303.
Lead breaks and dissolution events on the VNS Therapy™ System Lead Model 300 and Model 302 and the VNS Perennia Lead™ Model 303.
8.0 milliamp programming anomaly on the NCP pulse generators Model 100 and Model 101 and the VNS Therapy™ Pulse Generators Model 102 and Model 102R.
Handheld Screen Freeze using the VNS Therapy™ Programming System (Model 250) containing the Dell X5 handheld computer.