Eon Mini - 3721 (Charger). Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractabl

FDA device recall Z-1739-2013 · posted 2013-07-16 · Terminated

Recall details

Recalling firm

St. Jude Medical

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

Action taken

ST. Jude Medical sent an Important Medical Device Safety Information dated July 26, 2012 to affected customers. The letter identifed the affected product, problem and actions to be taken. For questions or concerns contact your ST. Jude Medical representative or St. Jude Medical Neuromodulation Division at 1-866-240-6741.

Root cause

Device Design

Status

Terminated

Product code

LGW

Quantity affected

70,638 (combined total of the Eon and the Eon Mini systems)

Distribution

Worldwide Distribution - USA Nationwide Including Puerto Rico and countries of: Argentina, Australia, Belgium, Brazil, Canada, China, Chile, Colombia, Ireland, Israel, India, Malaysia, Mexico, Saudi A

Date initiated

2012-07-26

Date posted

2013-07-16

Date terminated

2015-11-18

Location

Plano, TX