| Class 2 Device Recall Eon Mini | |
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
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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
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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 |
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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.
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PMA Database | PMAs with Product Code = LGW
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