Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid in the management of chronic int

FDA device recall Z-1983-2012 · posted 2012-07-10 · Terminated

Recall details

Recalling firm

Advanced Neuromodulation Systems Inc.

Reason for recall

The firm has received 112 complaints of the Eon Mini IPGs that lost the ability to communicate or recharge due to a workmanship issue resulting in loss of pain relief and subsequent explant. The firm has determined the cause of these reports to be related to process variances in the positioning of the internal battery and printed circuit board, causing a short, and therefore, prematurely depletin

Action taken

St. Jude Medical sent an Important Medical Device Recall letter dated December 19, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were issued the following instructions: For unimplated inventory of affected product customers should contact their SJM Representative to have the device returned to St. Jude Medical. A replacement device will be provided at no additional cost to them. For implanted affected product it is recommended that customers do not unnecessarily explant the devices associated with this advisory if the IPGs are functioning as intended. If there is a sudden loss of power or if the duration between recharges becomes significantly shorter, customers should contact their St. Jude Medical Representative. If device replacement is required due to IPG failure related to this voluntary recall notice, St. Jude Medical will provide a replacement IPG at no charge. For questions regarding this recall call 972-309-2154.

Root cause

Process design

Status

Terminated

Product code

LGW

Quantity affected

25, 255 devices

Distribution

Worldwide Distribution - USA (nationwide) and internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, In

Date initiated

2011-12-19

Date posted

2012-07-10

Date terminated

2015-07-24

Location

Plano, TX