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U.S. Department of Health and Human Services

Class 2 Device Recall Eon Mini

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  Class 2 Device Recall Eon Mini see related information
Date Initiated by Firm July 26, 2012
Date Posted July 31, 2013
Recall Status1 Terminated 3 on August 21, 2015
Recall Number Z-1836-2013
Recall Event ID 63108
PMA Number P010032S023 
Product Classification Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
Product Eon Mini - 3788 (IPG),

Eon Mini 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 Multiple lots recalled are the ones with supplier's inner battery lots of 326-508
Recalling Firm/
Manufacturer		 St. Jude Medical
6901 Preston Rd
Plano TX 75024-2508
For Additional Information Contact
972-309-2154
Manufacturer Reason
for Recall		 As part of St. Jude Medical's routine tracking and product monitoring, they have received a total of 214 reports, out of 34,617 Eon Mini IPGs, that lost the ability to communicate or recharge due to an inner battery weld issue resulting in loss of pain relief and subsequent explant. Explant surgery, as with any surgery, presents a risk to patient health. Adverse events associated with an unplanne
FDA Determined
Cause 2		 Device Design
Action St. Jude Medical sent a Important Medical Device Recall Advisory dated July 26, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. To further assist in your patient care we are providing you with a list of all serial numbers we show have been distributed to you. ( See Attachment A ). Further questions please call (972) 309-2154.
Quantity in Commerce 34,617
Distribution Worldwide Distribution--USA (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Belgium, Brazil, canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Saudi, 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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