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Terminated

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.

FDA Recall Z-1599-2010 · Posted 2010-05-13

Recalling FirmAdvanced Neuromodulation Systems, Inc
Recall StatusTerminated
Product CodeLGW
Date Initiated2010-04-23
Date Terminated2015-07-27
Product Quantity7 devices

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.

Firm 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.

Root Cause

Manufacturing material removal

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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