Recall Z-1563-2020

Reason for recall

False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3) In-session re-interrogation performed. Users instructed to lower output current and widen pulse width. Only system diagnostic testing evaluates output current. Users may conclude device malfunction, could lead to medical/surgical intervention.

FDA-determined cause: Software Design Change

Action taken

On 02/04/20, Urgent Medical Device Correction notices were mailed to Doctors, who were informed the following: Which Patients are Potentially Impacted? Because the false positive warning message only appears if the generator is initially interrogated at 0mA, there are only certain scenarios where the issue may appear: - After initial implant, when the device is programmed on for the first time; - Following an MRI, after the device was programmed to 0mA per labeling instructions; or - Resuming therapy following previous device disablement due to an adverse event or device issue. Actions to be taken by the Physician: 1. If you obtain the low output current warning message, follow the Physician's Manual instructions to perform a System Diagnostics test after initial interrogation and programming before utilizing in-session re-interrogation. 2. During programming visits, always perform System Diagnostics testing immediately after any programming operations are performed to ensure the device is delivering programmed stimulation as intended. 2. Please complete and return the attached Customer Response Form. Please ensure that this notice is communicated to all personnel within your organization who need to be aware of it. To report a complaint or for technical support, contact the Customer Quality team at cservices@livanova.com or (866) 882-8804. Actions to be taken by Company: An update to the software is in development to eliminate this false positive low output current message. Information on availability of the software update will be shared in future communications. New users will be trained on proper use of programming system, including the appropriate sequence of use of diagnostic testing.