• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Eon Mini

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
Eon Mini
see related information
Date Posted July 31, 2013
Recall Status1 Open
Recall Number Z-1836-2013
Recall Event ID 63108
Premarket Approval
PMA Number
P010032/S028
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, Texas 75024-2508
Consumer Instructions Contact the recalling firm for information
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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LGW and Applicant = ADVANCED NEUROMODULATION SYSTEM,INC
-
-