Eon Rechargeable Implantable Pulse Generator (IPG) System

FDA device recall Z-0170-2010 · posted 2009-11-10 · Terminated

Recall details

Recalling firm

Advanced Neuromodulation Systems, Inc

Reason for recall

Product's external charging system on occasion was failing to communicate with the Implantable Pulse Generator preventing re-charging of the pain relief system.

Action taken

12/22/2006, Marketing Update 5015 was issued to field sales representatives providing information on improving communication between the Internal Pulse Generator and its charger. May 15, 2007, Marketing Update 5022 was issued to field sales representatives to reiterate avoiding contact between the charger antenna and conductive materials and place the preferred side of the charging antenna face-down over the implant. Troubleshooting Guide was created in January 2008 for field sales representatives and technical services departments regarding isolation of the communication issue to the external devices instead of the implanted component. March 25, 2008, the Clinician's Manual was updated adding a recommendation for a minimum depth of pocket for device implantation.

Root cause

Device Design

Status

Terminated

Product code

LGW

Quantity affected

24,750 units total

Distribution

Worldwide

Date initiated

2006-12-22

Date posted

2009-11-10

Date terminated

2010-07-23

Location

Plano, TX