Recall Z-0994-2009
Cyberonics, Inc · initiated February 7, 2008
Product
Cyberonics VNS Therapy Demipulse Generator, Model 103; an implantable, multiprogrammable, vagus nerve stimulator.
Codes / lots: All lots.
Reason for recall
Reset/disabling of the VNS Therapy Demipulse Generator and Demipulse Duo Generator due to magnet interference resulting in the loss of stimulation.
FDA-determined cause: Software design
Action taken
Cyberonics notified consignees of recall via letter on 02/07/08. Consignees were notified of reset issue in which during a strong magnetic field, the software may report an error even though no error occurred. This error causes the generator to reset, which disables the generator (i.e., no stimulation delivered). Physicians should inform any potential and currently implanted patients of the possibility of this event. Patients should continue with their regularly scheduled visits as determined by their physician. If this event is suspected, physicians should interrogate the device as described in the Physicians Manual to confirm the generator has been reset and Cyberonics should be contacted for any additional instruction.
Details
- Recall number
- Z-0994-2009
- Initiated
- February 7, 2008
- Posted by FDA
- April 22, 2009
- Terminated
- February 28, 2011
- Product code
- LYJ – Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Quantity
- 687 units.
- Distribution
- Worldwide Distribution - USA, Belgium, Germany, Norway, Spain, Sweden, the Netherlands, and United Kingdom.
- Recalling firm
- Cyberonics, Inc, Houston, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0995-2009 | Cyberonics VNS Therapy Demipulse Duo Generator, Model 104; an implantable…Reset/disabling of the VNS Therapy Demipulse Generator and Demipulse Duo Generator due to magnet… | 02/07/2008Terminated |