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U.S. Department of Health and Human Services

Class 1 Device Recall SynchroMed II Implantable Drug Infusion System

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 Class 1 Device Recall SynchroMed II Implantable Drug Infusion Systemsee related information
Date Initiated by FirmOctober 03, 2016
Date PostedDecember 19, 2016
Recall Status1 Terminated 3 on June 02, 2022
Recall NumberZ-0788-2017
Recall Event ID 75486
PMA NumberP860004 
Product Classification Pump, infusion, implanted, programmable - Product Code LKK
ProductMedtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Product Usage: The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, Chronic intrathecal infusion of Lioresal Intrathecal (baclofen Injection ) in the management of serve spasticity, Chronic Intravascular Infusion of Floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer
Code Information software application cards with versions other than AAU01
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave
Minneapolis MN 55421-1241
For Additional Information ContactTechnical Services
800-707-0933
Manufacturer Reason
for Recall		Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for the SynchroMed Infusion System. Medtronic is updating the Model 8870 software application card (to version AAU01) and the SynchroMed pump labeling to address the priming bolus issue.
FDA Determined
Cause 2		Under Investigation by firm
ActionMedtronic Representatives began visiting consignees on 10/3/2016 to replace previous version Model 8870 software application cards, contained within the model 8840 N Vision Clinician Programmer, with the updated version (new version is AAU01). Beginning October 20, 2016, Implanting and Following physicians were sent an Urgent Medical Device Correction letter dated September 2016, . This letter to physicians is informing them of the updated Model 8870 software application card, and changes to SynchroMed infusion system labeling. A response form is requested to be returned to Medtronic. Customers with questions were instructed to contact Medtronic Neuromodulation Technical Services at 1-800-707-0933.
Quantity in Commerce22,298 software cards
DistributionWorldwide Distribution - (US Nationwide) Internationally to Germany, Greece, Australia, United Kingdom, Switzerland, Italy, Norway, France, Canada, and Malta.
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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