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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Product Detail

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

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 Letter
Distribution Pattern Worldwide Distribution - 53 consignees out of the US.
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