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U.S. Department of Health and Human Services

Class 2 Device Recall Eon IPG

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 Class 2 Recall
Eon IPG
see related information
Date Posted November 10, 2009
Recall Status1 Terminated on July 23, 2010
Recall Number Z-0170-2010
Recall Event ID 53128
Premarket Approval
PMA Numbers
P010032/S014 P010032/S019
Product Classification Stimulator, Spinal-Cord, Totally Implanted For Pain Relief - Product Code LGW
Product Eon Rechargeable Implantable Pulse Generator (IPG) System
Code Information Model number 3701 charging system is an accessory to the 3716 IPG; antennas are not serialized.
Recalling Firm/
Manufacturer
Advanced Neuromodulation Systems, Inc
6901 Preston Rd
Plano, Texas 75024-2508
Consumer Instructions Contact the recalling firm for information
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Device Design
Action 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.
Quantity in Commerce 24,750 units total
Distribution Worldwide
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LGW and Applicant = ADVANCED NEUROMODULATION SYSTEM,INC
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