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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Event Detail

Event ID 61554
Product Type Devices
Status Ongoing
Recalling Firm Advanced Neuromodulation Systems Inc.
City Plano
State TX
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-03-28
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution - 53 consignees out of the US.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator. Model number 6788. All lots manufactured prior to 03/16/2012 are being recalled. Class II Unintended Fluid ingress into the device header has been shown. 388 units Z-0894-2013