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U.S. Department of Health and Human Services

Class 2 Device Recall SynchroMed II Implantable Drug Infusion Pump

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 Class 2 Device Recall SynchroMed II Implantable Drug Infusion Pumpsee related information
Date Initiated by FirmFebruary 26, 2014
Date PostedMay 08, 2014
Recall Status1 Terminated 3 on September 28, 2018
Recall NumberZ-1570-2014
Recall Event ID 67720
PMA NumberP860004S056 
Product Classification Pump, infusion, implanted, programmable - Product Code LKK
ProductMedtronic SynchroMed II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter.
Code Information This Medical Device Correction notification affects all SynchroMed II pumps.
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave NE
Minneapolis MN 55432-3568
For Additional Information ContactDonna Marquard
763-526-6248
Manufacturer Reason
for Recall		This recall provides important new information regarding overinfusion associated with the Medtronic SynchroMed II Implantable Pump. Overinfusion can result in a life-threatening overdose and can also result in drug withdrawal due to premature emptying of the pump. Due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk, Medtronic is not re
FDA Determined
Cause 2		Under Investigation by firm
ActionMedtronic sent a "Urgent Medical Device Correction" letter dated March 2014. The letter was sent to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter provided the Explanation of the Issue, Scope and Severity, Recommendations, and Important Guidelines. Customer visits were started by Medtronic field Representatives on February 26th, 2014. Medtronic is communicating this information to the appropriate regulatory agencies globally, including the U.S. Food and Drug Administration. We are committed to continuing to improve our product performance and services to enable you to manage your patients in a safe and effective manner. If you have questions, please contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am- 6pm CST.
Quantity in Commerce195,198 pumps (146,435 US, 48,763 OUS)
DistributionWorldwide Distribution - All states in USA. OUS: List not provided at this time.
Total Product Life CycleTPLC Device Report
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.
PMA DatabasePMAs with Product Code = LKK
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