Eon Mini Implantable Pulse Generator (IPG)…

Date posted by the FDA

May 13, 2010

Status

Terminated

Filed by

Advanced Neuromodulation Systems, Inc

Product

Eon Mini Implantable Pulse Generator (IPG). Advanced Neuromodulation Systems, Inc. Plano, TX. Indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.

Reason

Due to a missed inspection step during manufacturing, a small number of devices may experience a gradual or sudden loss of charging capability.

Distribution pattern

Nationwide Distribution -- GA, NC, CA, OK, SC and NJ.

Quantity

7 devices

Codes and lots

Device Code: 65-3788-01, Serial Numbers: 703271, 703287, 703050, 703051, 704169, 704476 and 704520.

Recall started

April 23, 2010

Device type

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

Root cause (FDA)

Manufacturing material removal

What the company told customers

St. Jude Medical issued an "Important Medical Device Information" notification dated April 2010. Consignees were informed of the affected product and instructed on necessary steps. Any returned product should be sent to the firm. For further information, contact your St. Jude Medical Neuromodulation Division Sales Representative or call 1-972-309-2154.

Recall number

Z-1599-2010

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1599-2010. The agency record governs; check it and the company before acting.