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U.S. Department of Health and Human Services

Class 2 Device Recall VNS Therapy SenTiva Generator Model 1000

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  Class 2 Device Recall VNS Therapy SenTiva Generator Model 1000 see related information
Date Initiated by Firm August 13, 2019
Create Date February 10, 2020
Recall Status1 Terminated 3 on May 18, 2022
Recall Number Z-1118-2020
Recall Event ID 84710
PMA Number P970003 
Product Classification Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
Product VNS Therapy SENTIVA Generator Model # 1000

Labeling
26-0009-6800 Model 1000 Generator Sample Labels
26-0009-9600 Patient s Manual for Depression
26-0009-9500 Patient s Manual for Epilepsy
76-0000-5000 VNS Therapy System Physician s Manual
(refer to Attachment 1)
Code Information Model Serial No. UDI Model 1000 204460 01054250257504051119080317201205212044609910-0011-6102  Model 1000 183960 01054250257504051119080217200912211839609910-0011-6102  Model 1000 194980 01054250257504051119080217201030211949809910-0011-6102  Model 1000 204700 01054250257504051119080217201205212047009910-0011-6102  Model 1000 206720 01054250257504051119080317201219212067209910-0011-6102  Model 1000 213290 01054250257504051119080517210108212132909910-0011-6102  
Recalling Firm/
Manufacturer		 LivaNova USA Inc
100 Cyberonics Blvd
Houston TX 77058-2069
For Additional Information Contact Njemile Crawley
281-228-7575
Manufacturer Reason
for Recall		 Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications.
FDA Determined
Cause 2		 Process control
Action On 08/13/2019, the firm contacted via telephone hospitals/facilities of the immediate need to remove and replace the affected devices. Reference Firm email communication dated 1/27/2020. On 08/30/2019, prescribing physicians were telephone call with a follow-up email recommending replacement of the generators during an already planned or unrelated lead replacement surgery.
Quantity in Commerce 6 generators
Distribution US: FL, GA, KS, MO, and UT. No OUS distribution
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.
PMA Database PMAs with Product Code = LYJ and Original Applicant = LivaNova USA, Inc.
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