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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic, Model 8870, Application Software Card

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  Class 2 Device Recall Medtronic, Model 8870, Application Software Card see related information
Date Initiated by Firm March 12, 2012
Date Posted March 30, 2012
Recall Status1 Terminated 3 on April 29, 2016
Recall Number Z-1338-2012
Recall Event ID 61391
Product Classification Pump, infusion, implanted, programmable - Product Code LKK
Product Medtronic, Model 8870, Application Software Card is part of the SynchroMed¿ II Drug Infusion System. The System includes the SynchroMed¿ II implantable drug infusion pump 8637-20, 8637-40, N'Vision clinical programmer 8840 and the Software application card 8870.

The SynchroMed II Infusion system contains and administers prescribed drugs to a specific site inside patient body. The SynchroMed II Pump is supplied in 20 ml and 40 ml reservoir sizes. In the United States, the SynchroMed II Pump is specifically approved for (indicated): ¿ The chronic epidural/intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) in the treatment of chronic intractable pain. ¿ The chronic intrathecal infusion of Lioresal Intrathecal (baclofen injection) in the management of severe spasticity. ¿ The chronic intrathecal infusion of Prialt (preservative-free ziconotide sterile solution) for the management of severe chronic pain. ¿ The chronic intravascular infusion of floxuridine (FUDR) for the treatment of primary or metastatic cancer. ¿ The chronic intravascular infusion of methotrexate for the treatment of primary or metastatic cancer. Outside of the United States, the SynchroMed II Pump is indicated for the chronic infusion of drugs or fluids tested as compatible and listed in the product labeling for the specific geographies.
Code Information All Model 8870 software application cards containing SynchroMed II software are in scope for this action.
Recalling Firm/
Medtronic Neuromodulation
7000 Central Ave NE
Minneapolis MN 55432-3568
For Additional Information Contact
Manufacturer Reason
for Recall
Medtronic has confirmed that an algorithm used in the Model 8870 application card software has resulted in nine (9) occurrences of an incorrectly displayed Schedule to replace the pump by date. It is estimated that there are more than 140,000 SynchroMed II pump implants worldwide. A patient with a pump reaching EOS prior to replacement may experience the return of underlying symptoms and/or wit
FDA Determined
Cause 2
Software design
Action Medtronic mailed an "Urgent Medical Device Correction " letter addressed to Dear Healthcare Professional on March 12, 2012. The letter described the problem, Background, Clinical Manifestations, Recommendations, and Additional Information. To ensure there is no interruption in therapy, pump replacements should be scheduled before the ERI alarm sounds and the pump reaches its 7-year end of service. Customers were advised to forward the Urgent Medical Device Correction letter to patients whose name appears on their Pump Replacement List. Reimbursement SupportFor assistance with prior authorization, contact Medtronic Reimbursement at the numbers below: Therapy for Severe Spasticity: (800) 292-2903 Pain Therapies: (866) 962-9909 For questions regarding the letter call 800-328-0810.
Quantity in Commerce 6338
Distribution Nationwide Distribution
Total Product Life Cycle TPLC 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.