—#107986

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.

FDA product code: LKK — Pump, Infusion, Implanted, Programmable
Device class: Class 3
Medical specialty: Unknown
Affected lot / code info: All Model 8870 software application cards containing SynchroMed II software are in scope for this action.

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 7000 Central Ave NE, Minneapolis, Minnesota 55432-3568

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2012-03-12
Posted by FDA: 2012-03-30
Terminated: 2016-04-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107986. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.