St. Jude Medical Recalls Eon Mini Implantable Pulse Generators
St. Jude Medical is recalling 34,617 Eon Mini implantable pulse generators worldwide due to a battery weld issue that can cause loss of pain relief.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device failure leading to loss of therapeutic function and subsequent surgical intervention (explant), which presents a risk to patient health, but no specific injuries or deaths are reported in the source text.
Plain-English summary
St. Jude Medical is recalling 34,617 Eon Mini implantable pulse generators (IPGs) distributed worldwide, including in the United States, Puerto Rico, and numerous international markets. The recall is being conducted as part of the company's routine tracking and product monitoring.
The recall is due to an inner battery weld issue that can cause the device to lose the ability to communicate or recharge. This malfunction results in the loss of pain relief for patients. The affected units are identified by supplier's inner battery lots of 326-508.
St. Jude Medical has received 214 reports of devices experiencing this issue. The loss of function often leads to the surgical removal (explant) of the device. The source notes that explant surgery, as with any surgery, presents a risk to patient health.
The recalled product
- 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.
- Manufacturer
- St. Jude Medical
- Affected units
- 34,617
Distribution
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