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U.S. Department of Health and Human Services

Class 2 Device Recall Brio DBS System

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  Class 2 Device Recall Brio DBS System see related information
Date Initiated by Firm March 28, 2012
Date Posted February 28, 2013
Recall Status1 Terminated 3 on August 15, 2013
Recall Number Z-0894-2013
Recall Event ID 61554
Product Classification Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
Product Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
Code Information Model number 6788. All lots manufactured prior to 03/16/2012 are being recalled.
Recalling Firm/
Advanced Neuromodulation Systems Inc.
6901 Preston Rd
Plano TX 75024-2508
For Additional Information Contact Local SJM Representative
Manufacturer Reason
for Recall
Unintended Fluid ingress into the device header has been shown.
FDA Determined
Cause 2
Device Design
Action St. Jude Medical sent an Important Product Field Corrective Action Device Information letter dated March 28, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for any unused product, isolate the affected product for return to St. Jude Medical. Their local representatiave would collect the unused inventory. Any unused product would be replaced with product once inventory becomes available. For patients with implanted product and no degradation of therapy, it is recommended dthat the devices not be unnecesssarily explanted. For patient with implanted product who experience diminished or loss of therapy customers were advised to follow the steps provided in the letter. Customers were asked to forward the notification to any institution in the event one or more patients or products could be potentially affected by this action. Customers wsere asked to maintain a record of thenotice along with the recommendations to ensure the effectiveness of the communication. For questions regarding this recall call 972-309-2154.
Quantity in Commerce 388 units
Distribution Worldwide Distribution - 53 consignees out of the US.
Total Product Life Cycle TPLC 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.