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U.S. Department of Health and Human Services

Class 2 Device Recall VNS Therapy Programmer, Model 3000 v1.0 System

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  Class 2 Device Recall VNS Therapy Programmer, Model 3000 v1.0 System see related information
Date Initiated by Firm November 13, 2017
Create Date June 19, 2018
Recall Status1 Open3, Classified
Recall Number Z-2255-2018
Recall Event ID 80062
PMA Number P970003 
Product Classification Stimulator, autonomic nerve, implanted (depression) - Product Code MUZ
Product VNS Therapy Programmer, Model 3000, v1.0 System
Code Information Serial Numbers: FMT77F2, FKR57F2, FCR77F2, CJR77F2, BNT77F2, BNS77F2, 7XR77F2, 7XP57F2, 79R77F2, 90S77F2, 97Q57F2, 6NT77F2, 9GP57F2, 6KQ57F2,  B7Q57F2, 57P57F2, 55T77F2, J6R57F2, HWR77F2, 1G7G1F2, 1JR57F2,  9XP57F2, 4LR77F2, 4GT77F2, 4GR57F2, 2DT77F2, G2S77F2, FVQ77F2,  G5T77F2, FDQ57F2, F5R57F2, F2R57F2, F1Q57F2, GHS77F2, DVR77F2,  DNP57F2, DMYB7F2, DJS77F2, D1R57F2, CVQ57F2, H4R57F2, 85S77F2,  89T77F2, 8LYB7F2, 97YB7F2, 6MQ57F2, 6CQ57F2, 5HS77F2, JLQ57F2,  JGS77F2, 11R57F2, 1TQ57F2, 1YR77F2, 2DR77F2

FXP57F2 , FTR77F2, FPQ57F2, FNQ57F2, FLYB7F2, FFP57F2, GGT77F2, GSQ57F2, CMS77F2, H1R77F2, H3R57F2, 7LS77F2, 9KR57F2, 9NS77F2, 65R57F2, B8R77F2,  B9T77F2, 5D0C7F2, B9YB7F2, BJR57F2, JCQ57F2, J9YB7F2, HMYB7F2, CDQ57F2, FXQ57F2, G5S77F2, G3R77F2, FRQ57F2, G7YB7F2, FLS77F2, G90C7F2, FGR77F2, FFT77F2, G9Q57F2, FCT77F2, G9R57F2, F9YB7F2,  F9S77F2, F8T77F2, GDQ57F2, F7R57F2, F4T77F2, DWR77F2, DTR77F2,  DSQ57F2, GMQ57F2, DLS77F2, DH0C7F2, DGS77F2, DGP57F2, GZR77F2, D1Q57F2, CSQ57F2, CLS77F2, C9YB7F2, C70C7F2, H1R57F2, C1R77F2,  7MS77F2, 78YB7F2, 9SQ57F2, 5VQ57F2, 5RQ57F2, B60C7F2, 5NQ57F2, 5MR77F2, 5KS77F2, B8T77F2, BHP57F2, BJR77F2, 4JS77F2, H4T77F2,  JZQ57F2, JMS77F2, JMQ57F2, JG0C7F2, JBQ57F2, J8T77F2

HZQ57F2, J7R57F2, HVR77F2, HTP57F2, HNS77F2, HMQ57F2, HKQ57F2, H7S77F2,  D3R57F2, 1CQ57F2, 1HT77F2, 1MYB7F2, 2CP57F2, 2LYB7F2, CLYB7F2,  CMYB7F2, B4R77F2, B2S77F2, B0R57F2, 9QS77F2, D8Q57F2, 960C7F2, 95T77F2, 8JR77F2, 8HR57F2, BXP57F2, BWR77F2, BTQ77F2, C8YB7F2,  C60C7F2, BLR77F2, BLQ57F2, BGR77F2, BGP57F2, CHQ57F2, CKR57F2, CPP57F2, CSR77F2, CTQ77F2, CXR77F2, 9MS77F2, 9JR77F2, 9DQ57F2, D7S77F2, 94T77F2, 8PQ57F2, BWQ77F2, BSR77F2, BNQ57F2, C9R57F2, C8R57F2, C5R57F2, CF0C7F2, C3R57F2, CFP57F2, BDT77F2, B9S77F2, B5R57F2, CPQ57F2, B4R57F2, D2R57F2, 9KQ57F2, D5R77F2, 9F0C7F2, 980C7F2, D9YB7F2, 8WR77F2, DB0C7F2, 9P7G1F2, D3S77F2, D6R57F2, D7R57F2, 9CR77F2, 9G0C7F2, 96R57F2, DFP57F2, C0S77F2, BN7G1F2, BQ7G1F2, C8S77F2, CB0C7F2, CCR77F2, BHR57F2, CHP57F2, BCR77F2, BBR77F2, BB0C7F2, B90C7F2, B70C7F2, B2R57F2, 9VP57F2, 9TQ57F2, 9GR57F2, 9FP57F2, 9BS77F2

98R57F2 ,D80C7F2, 970C7F2, D8YB7F2, 95R77F2, 8YR77F2, C1R57F2, C80C7F2, C3R77F2, CNS77F2, 9VQ77F2, D4T77F2, 9DR77F2, 91R57F2, 8VQ77F2, 8RQ57F2, DBS77F2, 8JS77F2, C0R57F2, BTR77F2, BMYB7F2, BKR77F2, BBP57F2 and B8S77F2 
Recalling Firm/
Manufacturer
Cyberonics, Inc
100 Cyberonics Blvd
Houston TX 77058-2069
For Additional Information Contact Clinical Technical Support
866-882-8804
Manufacturer Reason
for Recall
Certain Model 3000 programming events can result in miscalculation of parameters stored in the Models 103, 104, 105, and 106 generators. During these programming events, the miscalculations can lead to: " Delivery of more stimulation than intended, resulting in painful stimulation or other common side effects (Model 106 only); " No stimulation in the case of device disablement (Burst Watchdog Timeout), resulting in no therapy to the patient (Model 106 only); " Delivery of less stimulation than intended, resulting in therapeutic settings not being achieved within device specification (Models 103, 104, 105, or 106); and/or " Delays or absence of the 75% and 50% battery life indicators displayed by the programming software (Models 103, 104, 105, or 106).
FDA Determined
Cause 2
Device Design
Action On November 13, 2017 LivaNva sent letters to all the doctor and surgeons that use this device. "Dear Doctor: This notification describes an issue identified with the VNS Therapy ¿ Programmer, Model 3000 version 1.0 which may impact patients implanted with Models 103, 104, 105 or 106 VNS Therapy generators. This issue does not affect Model 1000 SenTiva or Model 102/102R generators. What is the Issue? Certain programming events performed with a Model 3000 Programmer on a Model 103, 104, 105 or 106 VNS Therapy generator can result in a miscalculation of some parameters stored in the generator, which could lead to: " Output current delivered being different than that programmed; " Device disablement; and/or " Errors in the 75% and 50% battery life indicators. The actual battery life and battery function are not affected by this issue. Risk to Health This issue presents the following risks: " Delivery of more stimulation than intended, resulting in painful stimulation or other common side effects 1 (Model 106 only); " No stimulation in the case of device disablement, resulting in no therapy to the patient (Model 106 only); " Delivery of less stimulation than intended, resulting in therapeutic settings not being achieved (Models 103, 104, 105 or 106) ; or " Sudden decrease from 100% to 25% battery life indicator, though the actual battery life and battery function are not affected (Models 103, 104, 105). Which Patients are Potentially Impacted? Any patient with a Model 103, 104, 105 or 106 generator that has been programmed using a Model 3000 programmer may be affected by this issue. Your LivaNova representative will collect data from your Model 3000 programmer to identify which patients are impacted by this notice. Actions to be taken by the Physician 1. Stop using the Model 3000 programmer to program Model 103, 104, 105 or 106 generators. You shall continue using the Model 3000 programmer with Model 1000 SenTiva generators and may continue to use it wi
Quantity in Commerce 252
Distribution AL, CA, CO, DE, FL, GA, ID, IL, IN, ME, MO, MS, NC, NJ, NY, PA, TN, TN, TX, UT, WA and WI
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 = MUZ and Original Applicant = LivaNova USA, Inc.
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