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U.S. Department of Health and Human Services

Class 2 Device Recall Eon Mini Neurostimulation Sysem

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  Class 2 Device Recall Eon Mini Neurostimulation Sysem see related information
Date Initiated by Firm May 24, 2011
Date Posted June 22, 2011
Recall Status1 Terminated 3 on July 21, 2015
Recall Number Z-2607-2011
Recall Event ID 56787
PMA Number P010032S023 
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
Product Eon Mini Neurostimulation (IPG) System Model 3788

System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Code Information Serial numbers 701029 through 13766511. Serial numbers containing supplier battery lot numbers 285 and below.
Recalling Firm/
Manufacturer		 Advanced Neuromodulation Systems Inc.
6901 Preston Rd
Plano TX 75024-2508
For Additional Information Contact
972-309-2154
Manufacturer Reason
for Recall		 Defective battery was identified as cause for reports of inability to communicate or recharge the product.
FDA Determined
Cause 2		 Process control
Action St. Jude Medical sent an "IMPORTANT MEDICAL DEVICE RECALL" letter dated May 24, 2011 to all affected customers. The letter describes the product, problem and actions to be taken by the customers. St. Jude Medical recommends no action be taken if the product serial numbers do not match the numbers listed in the letter. For product remaining in unimplanted inventory, customers are instructed to contact their SJM representative so that product may be returned and replacements be provided. For implanted product that matches the serial numbers, the Medical Advisory Board recommend not to unnecessarily explant the devices if they are functioning as intended. Replacement devices will be provided at no additional cost to the customer. A Product Reconciliation Form was attached to the letter for customers to complete and return any unused product to the St. Jude Medical Neuromodulation Division at 6901 Preston Road., Plano, TX 75024. Questions regarding this recall are directed to the customer's St. Jude Medical Neuromodulation Division Representative.
Quantity in Commerce 17,141
Distribution Worldwide Distribution-- USA (nationwide) including PUERTO RICO and countries of AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, FINLAND,FRANCE, GERMANY, GREECE, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, MEXICO, NETHERLANDS, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, 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.
PMA Database PMAs with Product Code = LGW and Original Applicant = Abbott Medical
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