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U.S. Department of Health and Human Services

Class 2 Device Recall VNS Therapy M1000D SenTiva Generator

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  Class 2 Device Recall VNS Therapy M1000D SenTiva Generator see related information
Date Initiated by Firm November 12, 2020
Create Date December 04, 2020
Recall Status1 Terminated 3 on January 12, 2023
Recall Number Z-0535-2021
Recall Event ID 86776
Product Classification Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
Product VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode.
Code Information Model Number - Model 1000-D Serial Numbers: 311298 310443 310068 310353 310531 310351 310380 310348 
Recalling Firm/
Manufacturer		 LivaNova USA Inc
100 Cyberonics Blvd
Houston TX 77058-2069
For Additional Information Contact
281-228-7200
Manufacturer Reason
for Recall		 During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.
FDA Determined
Cause 2		 Device Design
Action On 10/09/2020, the firm hand-delivered an "URGENT: FIELD SAFETY NOTICE" informing its customers that in the event that a generator reset occurs (whether due to troubleshooting efforts or a device issue), the device will erroneously display the incorrect model number as "Model 1000 on the device In-Session programmer screen. The risk to patients could potentially be when the patient undergoes a future generator replacement surgery. Actions Physicians are to take: 1. Model 1000-D devices susceptible to this issue are provided in Attachment 1. When interrogating the generator and performing diagnostic testing per labeling, verify that the In-Session screen displays M1000-D. 2. If an interrogation of the generator is found to display M1000 In-Session or on the Session Report after interrogation, contact Customer Quality at (281) 228-7330 (Monday to Friday, 8 AM to 5 PM CST) or their local sales representative to report the event and for troubleshooting assistance. 3. To complete and return the attached Customer Response Form by fax to (281) 853-1248 or by e-mail to LivaNova.FSCA@livanova.com. The Recalling Firm is developing a device update that will eliminate the possibility for this erroneous model number display and expects that update to be available later in 2020. The Recalling Firm will contact its customers to schedule a visit to update the implanted device. For questions about this Medical Device Correction, contact Customer Quality at +1 (281) 228-7330 (Monday to Friday, 8 AM to 5 PM CST) or e-mail at cservices@LivaNova.com.
Quantity in Commerce 8 generators
Distribution International distribution in the countries of Austria and United Kingdom.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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