Recall Z-1739-2013— St. Jude Medical
Class II · Terminated
Class II FDA medical device recall by St. Jude Medical, initiated 2012-07-26, terminated 2015-11-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Eon Mini - 3721 (Charger). Product Usage: 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.. Reason: 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 Medica.
- Recalling firm
- St. Jude Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-07-26
- Terminated
- 2015-11-18
- Firm location
- Plano, TX, United States
Product description
Eon Mini - 3721 (Charger). Product Usage: 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.
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 Medica
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