Class 1 Device Recall SynchroMed II Implantable Infusion Pump

• Date Initiated by Firm: June 03, 2013
• Date Posted: June 25, 2013
• Recall Status: Terminated on May 14, 2015
• Recall Number: Z-1570-2013
• Recall Event ID: 65135
• PMA Number: P860004S056
• Product Classification: Pump, infusion, implanted, programmable - Product Code LKK
• Product: Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. ; ; Product Usage:; ; 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.; ; ; 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: all SynchroMed II pumps
• Recalling Firm/ Manufacturer: Medtronic Neuromodulation; 7000 Central Ave NE; Minneapolis MN 55432-3568
• For Additional Information Contact: Technical Services; 800-707-0933
• Manufacturer Reason for Recall: Medtronic is providing Healthcare Professionals with important safety information and patient management recommendations regarding the unintended delivery of drug during the priming bolus function for the SynchroMed implantable infusion pump. The unintended delivery of drug can contribute to patient overdose or underdose symptoms which may be clinically relevant.
• FDA Determined Cause: Device Design
• Action: Medtronic sent an Urgent Medical Device Correction letter dated May 2013, to all affected customers. The letter described the background and nature of the issue and provided recommendations for patient management and monitoring after initiation of Intrathecal Therapy. The letter directed customers to continue to use the priming bolus precedure; to monitor all patients following start or restart of intrathecal therapy; consider priming the pump prior to implant; and educate caregivers and family members to recognize the signs and sypmtoms associated with intrathecal drug therapy complications. For questions contact your local Medtronic field representative or Medtronic Neuromodulation Technical Services at 1-800-707-0933.
• Quantity in Commerce: 261,109 total devices estimated implanted Worldwide
• Distribution: Worldwide Distribution - USA Nationwide
• 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.

• PMA Database: PMAs with Product Code = LKK and Original Applicant = MEDTRONIC Inc.