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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Product Detail

Product Description Eon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon 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. Eon Mini: 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.
Recall Number Z-1738-2013
Classification Class II
Code Info All serial numbers manufactured
Product Distributed Qty 70,638 (combined total for Eon and Eon mini systems)
Reason For Recall St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their spinal cord stimulator. In three cases, patients received a burn to the skin (one second-degree and two first-degree burns) at the implant site. As of June 30, 2012, St. Jude Medical has received 127 total patient complaints of warmth or heating at the IPG implant site during charging for the Eon IPG and 198 reports of similar symptoms for the Eon Mini IPG. These reports resulted in total of 29 explants for Eon IPGs and 43 explants for Eon Mini IPGs. As of June 30, 2012, they have received three reports of skin surface burns (one 2nd degree and two 1st degree burns) believed to be associated with heating during charging. Explant surgery, as with any surgery, presents a risk to patient health. Adverse events associated with an unplanned surgery may be comparable to adverse events associated with planned operations, and may include pain, scarring, and infection, as well as complications from anesthesia.

Event Detail

Event Id 63109
Product Type Devices
Status Ongoing
Recalling Firm St. Jude Medical
City Plano
State TX
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-26
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - USA Nationwide Including Puerto Rico and countries of: Argentina, Australia, Belgium, Brazil, Canada, China, Chile, Colombia, Ireland, Israel, India, Malaysia, Mexico, Saudi Arabia, Singapore, South Africa, South Korea, Switzerland and United Kingdom.
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