Reported Aug 7, 2013 · Terminated
Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic intractable pain of the…
St. Jude Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: St. Jude Medical · 6901 Preston Rd · Plano, TX · 75024-2508
Is this the product you have?
- 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 followingfailed back, surgery syndrome, intractable low back and leg pain
- Lot codes and dates
- Multiple lots recalled are the ones with supplier's inner battery lots of 326-508
- Amount recalled
- 34,617
Where it was sold
- Nationwide
- PR
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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