Cyberonics VNS Therapy Demipulse Generator, Model 103; an implantable, multiprogrammable, vagus nerve stimulator.

FDA device recall Z-0994-2009 · posted 2009-04-22 · Terminated

Recall details

Recalling firm

Cyberonics, Inc

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.

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.

Root cause

Software design

Status

Terminated

Product code

LYJ

Quantity affected

687 units.

Distribution

Worldwide Distribution - USA, Belgium, Germany, Norway, Spain, Sweden, the Netherlands, and United Kingdom.

Date initiated

2008-02-07

Date posted

2009-04-22

Date terminated

2011-02-28

Location

Houston, TX