Class 2 Device Recall VNS Therapy Programmer

• Date Initiated by Firm: February 04, 2020
• Create Date: March 24, 2020
• Recall Status: Open, Classified
• Recall Number: Z-1563-2020
• Recall Event ID: 84723
• PMA Number: P970003
• Product Classification: Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
• Product: VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.
• Code Information: Model 3000 version 1.6
• Recalling Firm/ Manufacturer: LivaNova USA Inc; 100 Cyberonics Blvd; Houston TX 77058-2069
• For Additional Information Contact: 281-228-7200
• Manufacturer 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: 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.
• Quantity in Commerce: 2683
• Distribution: U.S.: LA, ID, AZ, UT, KY, VA, TN, NY, SC, IL, IN, NC, WA, CA, OH, FL, PA, NJ, CO, TX, RI, MD, HI, OR, MA, NE, MO, OK, MS, MN, SD, VT, AR, WV, WI, MI, AL, KS, DE, NM, GA, ND, AK, MT, ME, NV, DC, MO, WY, IA, CT. Canada, and Israel.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = LYJ and Original Applicant = LivaNova USA, Inc.