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U.S. Department of Health and Human Services

Class 1 Device Recall SynchroMed II implantable infusion pump

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 Class 1 Recall
SynchroMed II implantable infusion pump
see related information
Date Posted December 13, 2012
Recall Status1 Open
Recall Number Z-0497-2013
Recall Event ID 63712
Premarket Approval
PMA Number
P860004
Product Classification Pump, Infusion, Implanted, Programmable - Product Code LKK
Product Medtronic SynchroMed II, Model 8637, (The SynchroMed® II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories.
Code Information All SynchroMed EL and SynchroMed II pumps
Recalling Firm/
Manufacturer
Medtronic Neuromodulation
7000 Central Ave NE
Minneapolis, Minnesota 55432-3568
For Additional Information Contact Medtronic Technical Services
800-707-0933
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action The firm Medtronic, sent an "Urgent medical Device Safety Notification" dated November 2012, to its customers beginning November 09, 2012. The letter described the product, problem and actions to be taken. The customers were instructed to follow the recommendations provided in the letter and complete and return the PHYSICIAN REPLY FORM via mail at Medtronic Neuromodulation Quality Assurance, 7000 Central Ave NE, Mailstop RCC150, Minneapolis, MN 55432; fax to: 800-897-3899 or email to: neuro.quality@medtronic.com. If you have questions, please contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am - 6pm CST.
Quantity in Commerce 174,700 devices total
Distribution Worldwide distribution: USA (nationwide) and countries including: Canada and Mexico.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = LKK and Applicant = MEDTRONIC INC.
PMAs with Product Code = LKK and Applicant = MEDTRONIC NEUROLOGICAL
PMAs with Product Code = LKK and Applicant = MEDTRONIC NEUROMODULATION
PMAs with Product Code = LKK and Applicant = MEDTRONIC VASCULAR
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