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U.S. Department of Health and Human Services

Class 2 Device Recall Eon Mini" Implantable Pulse Generator (IPG)

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  Class 2 Device Recall Eon Mini" Implantable Pulse Generator (IPG) see related information
Date Initiated by Firm April 23, 2010
Date Posted May 13, 2010
Recall Status1 Terminated 3 on July 27, 2015
Recall Number Z-1599-2010
Recall Event ID 55503
PMA Number P010032-S023 
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
Product Eon Mini Implantable Pulse Generator (IPG). Advanced Neuromodulation Systems, Inc. Plano, TX.

Indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.
Code Information Device Code: 65-3788-01, Serial Numbers: 703271, 703287, 703050, 703051, 704169, 704476 and 704520.
Recalling Firm/
Manufacturer		 Advanced Neuromodulation Systems, Inc
6901 Preston Rd
Plano TX 75024-2508
Manufacturer Reason
for Recall		 Due to a missed inspection step during manufacturing, a small number of devices may experience a gradual or sudden loss of charging capability.
FDA Determined
Cause 2		 Manufacturing material removal
Action St. Jude Medical issued an "Important Medical Device Information" notification dated April 2010. Consignees were informed of the affected product and instructed on necessary steps. Any returned product should be sent to the firm. For further information, contact your St. Jude Medical Neuromodulation Division Sales Representative or call 1-972-309-2154.
Quantity in Commerce 7 devices
Distribution Nationwide Distribution -- GA, NC, CA, OK, SC and NJ.
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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