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U.S. Department of Health and Human Services

Class 2 Device Recall Eon IPG

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 Class 2 Device Recall Eon IPGsee related information
Date Initiated by FirmDecember 22, 2006
Date PostedNovember 10, 2009
Recall Status1 Terminated 3 on July 23, 2010
Recall NumberZ-0170-2010
Recall Event ID 53128
PMA NumberP010032/S14/ 
Product Classification spinal pulse generator - Product Code LGW
ProductEon 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 TX 75024-2508
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		Device Design
Action12/22/2006, 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 Commerce24,750 units total
DistributionWorldwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = LGW
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