FDAFDA · Food and drugs·Recall number Z-1836-2013
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.
Published August 7, 2013 · Recall initiated: July 26, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- St. Jude Medical
- Distributor
- 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.
- Lot
- Multiple lots recalled are the ones with supplier's inner battery lots of 326-508
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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