St. Jude Medical Eon and Eon Mini News and Recall Information

By admin on 7/26/2012 11:41 AM
On July 26, 2012, St. Jude Medical provided an update letter to physicians regarding the Eon Mini™ implantable pulse generator. This is an update to the previous voluntary recall notification letter, dated May 24, 2011. See both letters below:

Updated Medical Device Information: Eon Mini™ IPG – July 2012 [PDF] Important Medical Device Information: Eon Mini™ IPG – May 2011 [PDF]...
By admin on 7/26/2012 11:36 AM
On July 26, 2012, St. Jude Medical provided an update letter to physicians regarding Eon™ and Eon Mini™ implantable pulse generators. This is an update to the previous voluntary device correction letter, dated December 19, 2011. See both physician letters and a patient safety information letter below:  Updated Medical Device Information: Eon™ and Eon Mini™ IPGs – July 2012 [PDF]  Important Medical Device Information: Eon™ and Eon Mini™ IPGs – December 2011 [PDF] ...
By admin on 12/19/2011 8:29 AM
Re: Eon Mini™ Product Code 65-3788 (Spinal Cord Stimulator) Manufactured Before September 30, 2010 Dear Physician, This letter provides important information pertaining to the Eon Mini implantable pulse generators (IPGs) manufactured before September 2010. As part of St. Jude Medical’s routine tracking and product monitoring, we have received 112 reports of Eon Mini IPGs that lost the ability to communicate or recharge due to a workmanship issue resulting in loss of pain relief and subsequent explant. After thorough analysis, we have determined the cause of these reports to be related to process variances in the positioning of the internal battery and printed circuit board, causing a short, and therefore, prematurely depleting battery voltage. Our post-marketing surveillance received 112 reports of premature battery depletion out of the 25,255 devices covered by this voluntary recall. View Complete Letter
By admin on 9/30/2010 3:22 PM
The Eon Mini spinal cord stimulator -- world's smallest, longest-lasting rechargeable neurostimulator to manage chronic pain -- combines greater patient comfort with 10-year battery longevity  ST. PAUL, Minn., Sep 30, 2010 (BUSINESS WIRE) --

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) of the Eon Mini(TM) spinal cord stimulation (SCS) system. The world's smallest, longest-lasting rechargeable neurostimulator, the Eon Mini device is the first rechargeable spinal cord stimulator to be approved for use in Japan. Spinal cord stimulators manage chronic painof...
By admin on 11/18/2009 2:29 PM
St. Jude Medical receives Chinese State Food and Drug Administration approval for Eon and Genesis neurostimulators for chronic pain

ST. PAUL, Minn.--(BUSINESS WIRE)--Nov. 18, 2009-- St. Jude Medical, Inc. (NYSE:STJ) announced today that a 62-year-old man from Shenzhen, Guangdong province has become the first patient in China to be implanted with the Eon™ neurostimulator, a rechargeable device used to help manage chronic pain. Despite prior back surgeries, the patient suffered from chronic back pain for more than a decade.

The Eon neurostimulator, which is the first rechargeable spinal cord stimulator to be approved for use in China, was recently approved by the Chinese State Food and Drug Administration (SFDA) for the management of chronic low back pain and pain from back surgeries that have failed.

“Chronic pain is a serious health issue in China,” said Professor  Zhang De Ren , M.D., an interventional pain physician at the Shenzhen Nanshan Hospital of Shenzhen, Guangdong province who performed...
By admin on 2/24/2009 1:17 PM
Eon Mini neurostimulator is approximately the size of a matchbox and combines patient comfort with 10-year battery longevity ST. PAUL, Minn.--(BUSINESS WIRE)--Feb. 24, 2009-- St. Jude Medical, Inc. (NYSE:STJ) today announced Australian Therapeutic Goods Administration (TGA) approval of the Eon Mini™ neurostimulator, the world’s smallest, longest-lasting rechargeable device in its class to treat chronic pain of the trunk or limbs and pain from failed back surgery. In Australia, the Eon Mini neurostimulator is reimbursable via the private health system.

Approximately the size of a matchbox, the Eon Mini neurostimulator has a thin 10 mm profile and weighs 29 grams (approximately 1 oz). Its small size allows for a smaller incision, giving the physician more control in selecting the optimal implant location. Additionally, the device has the greatest recommended implant depth of any small rechargeable neurostimulator. For patients, the Eon Mini neurostimulator’s thin profile, implant depth and small size allow...
By admin on 9/17/2008 11:14 AM
Silver dollar-sized medical device provides injured military skydiver with pain relief

ST. PAUL, Minn.--(BUSINESS WIRE)--Sept. 17, 2008--St. Jude Medical, Inc. (NYSE:STJ) today announced the first patient implant of an Eon Mini(TM), the world's smallest, longest-lasting, rechargeable neurostimulator to treat chronic pain of the trunk or limbs and pain from failed back surgery.

A 26-year-old patient was implanted with the Eon Mini neurostimulator, a medical device which is slightly larger than a U.S. silver dollar. Similar in function and appearance to a cardiac pacemaker, the neurostimulator delivers mild electrical pulses to the spinal cord, which interrupt or mask the pain signals' transmission to the brain.

The patient, Adam Hammond, is a former member of the U.S. Army "Golden Knights" Parachute Team. Hammond was skydiving while on leave in 2006 when his parachute did not deploy correctly. He hit the ground in excess of 45 miles an hour.

"As soon as I hit the ground, I thought, 'God,...
By admin on 8/13/2008 11:12 AM
New device offers physicians new option for treating pain patients

ST. PAUL, Minn.--(BUSINESS WIRE)--Aug. 13, 2008--St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug Administration (FDA) and European CE Mark approvals of EonC(TM), the first extended-life primary cell (non-rechargeable) neurostimulator for the treatment of chronic pain.

The EonC neurostimulator provides a convenient option for chronic pain patients who prefer or require the simplicity of a non-rechargeable medical device. Featuring the greatest battery capacity of any primary cell neurostimulator, the EonC may maximize the time between device replacement procedures.

"Selecting the right system for each patient is vital for the success of spinal cord stimulation (SCS) therapy," said Chris Chavez, president of the St. Jude Medical ANS Division. "With chronic pain, there's no such thing as a 'one size fits all' approach. For some patients, a non-rechargeable device like EonC provides the perfect solution for...

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