Z-1599-2010

Eon Mini Implantable Pulse Generator (IPG). Advanced Neuromodulation Systems, Inc. Plano, TX. Indicated as an...

Name: Z-1599-2010 Eon Mini Implantable Pulse Generator (IPG). Advanced Neuromodulation Systems, Inc. Plano, TX. Indicated as an...
Creator: Advanced Neuromodulation Systems, Inc
Published: 2010-04-23
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-04-23 / Terminated / root cause: manufacturing process

FDA source

Advanced Neuromodulation Systems, Inc began a recall of Eon Mini Implantable Pulse Generator (IPG). Advanced Neuromodulation Systems, Inc. Plano, TX. Indicated as an aid in the management of chronic, intractable... on 2010-04-23. The reason FDA records is "Due to a missed inspection step during manufacturing, a small number of devices may experience a gradual or sudden loss of charging capability". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1599-2010
Status: Terminated
Initiated: 2010-04-23
Posted: 2010-05-13
Terminated: 2015-07-27
Recalling firm: Abbott Medical
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.
Product code: LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Reason for recall: Due to a missed inspection step during manufacturing, a small number of devices may experience a gradual or sudden loss of charging capability.
Root cause tag: manufacturing process
FDA root cause: Manufacturing material removal
Action: 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.
Quantity in commerce: 7 devices
Distribution: Nationwide Distribution -- GA, NC, CA, OK, SC and NJ.
Product codes and lots: Device Code: 65-3788-01, Serial Numbers: 703271, 703287, 703050, 703051, 704169, 704476 and 704520.

Product code LGW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)