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U.S. Department of Health and Human Services

Enforcement Report - Week of December 19, 2012

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Product Detail

Product Description SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. implantable infusion pump. The pump is part of an implanted infusion system that consists of a SynchroMed EL pump and a catheter. The SynchroMed EL Infusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The SynchroMed EL Infusion System with a 10 mL reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids referred to in this manual.
Recall Number Z-0496-2013
Classification Class I
Code Info All SynchroMed EL and SynchroMed II pumps
Product Distributed Qty 174,700 devices total
Reason For Recall Medtronic notified Healthcare Professionals of the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. Use of unapproved drugs with SynchroMed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion.

Event Detail

Event Id 63712
Product Type Devices
Status Ongoing
Recalling Firm Medtronic Neuromodulation
City Minneapolis
State MN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-09
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide distribution: USA (nationwide) and countries including: Canada and Mexico.