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The Eon Mini Implantable Pulse Generator (IPG) is a… recallZ-0025-2013 · Advanced Neuromodulation Systems Inc. · initiated Sep 4, 2012

Class II Terminated All recalls posted in October 2012

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 Advanced Neuromodulation Systems Inc. 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

Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimulation that would be felt by the patient as uncomfortable or painful. SJMs routine testing, monitoring, and analysis of manufacturing processes identified three lots of Eon Mini IPGs that the internal battery has the potential to come into contact with the internal microcontroller board.

FDA root cause category: Nonconforming Material/Component

What the company is doing

ST. Jude Medical sent an important Medical Device Advisory letter dated September 4, 2012 to all affected customers. The letter identified the affected product, problem and recommended actions to be taken. For questions contact your St. Jude Medical Neuromodulation Division Representative or call the Technical Services Department at 1-800-727-7846.

Recall details

Recall number
Z-0025-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Sep 4, 2012
Posted by the FDA
Oct 9, 2012
Recalling firm
Advanced Neuromodulation Systems Inc.
Quantity
56 units
Product code
LGW
FDA submissions
P010032
Distribution
US Nationwide Distribution

Product description

The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. 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.

Code information (models, lots, serial numbers)

Eon Mini - 3788 (IPG), Multiple Serial Numbers

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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