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Eon - 3701 (Wall Charger) and 3711 (Portable Charger) recallZ-1738-2013 · St. Jude Medical · initiated Jul 26, 2012

Class II Terminated All recalls posted in July 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from St. Jude Medical or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1738-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Jul 26, 2012
Posted by the FDA
Jul 16, 2013
Recalling firm
St. Jude Medical
Quantity
70,638 (combined total for Eon and Eon mini systems)
Product code
LGW
FDA submissions
P010032
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 Arabia, Singapore, South Africa, South Korea, Switzerland and United Kingdom.

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.

Code information (models, lots, serial numbers)

All serial numbers manufactured

Other devices under the same FDA submission

110 devices cleared under P010032 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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