Date Initiated by Firm | November 09, 2012 |
Date Posted | December 13, 2012 |
Recall Status1 |
Terminated 3 on December 31, 2017 |
Recall Number | Z-0497-2013 |
Recall Event ID |
63712 |
PMA Number | P860004S042 |
Product Classification |
Pump, infusion, implanted, programmable - Product Code LKK
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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 MN 55432-3568
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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.
UPDATE 2/1/2016: Medtronic received approval to incorporate enhancements to the SynchroMed II pump which decreases the potential for internal electrical shorting and motor corrosion, and is retrieving any unused pumps. |
FDA Determined Cause 2 | 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.
UPDATE 2/1/2016: Medtronic began notifying consignees 2/1/2016 via, mail, telephone and/or in person visit by a Medtronic Field Representative. The Medtronic Field Representatives will retrieve devices in the US and provide an Urgent Medical Device Removal letter. The letter states that device design has been updated and the Medtronic Field Representative has retrieved any devices with a Use By date on or before 5/14/2017. An account specific Customer Confirmation Form was to be completed by either the Medtronic Field Representative or the consignee. Consignees with questions can contatct their Medtronic Field Representative, or Customer Service at 1-888-854-0978. |
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 |
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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.
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PMA Database | PMAs with Product Code = LKK
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