| Class 2 Device Recall Medtronic SynchroMed II Programmable Pump | |
Date Initiated by Firm | August 25, 2008 |
Date Posted | January 26, 2009 |
Recall Status1 |
Terminated 3 on May 17, 2012 |
Recall Number | Z-0592-2009 |
Recall Event ID |
49603 |
PMA Number | P860004S056 |
Product Classification |
Pump, infusion, implanted, programmable - Product Code LKK
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Product | Medtronic SynchroMed II Programmable Pump, Model 8637-40. 40 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed II programmable Pump is part of the SynchroMed II Infusion System designed to contain and administer prescribed drugs to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA.
The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the follosing drugs or fluids: -chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of preservative-free morphine sulfate sterile solution. - chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of serve chronic pain. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of preservative-free ziconotide sterile solution after the initial fill of the pump with this drug. -chronic intrathecal infusion of Lioresal Intrathecal (baclofen injection) in the management of severe spasticity. Preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of Lioresal Intrathecal (baclofen Injection). -Chronic intravascular infusion of floxuridine, (FUDR) or methotrexate for the treatment of primary or metastatic cancer. Bacteriostatic water or preservative-free sterile saline, USP, can be used to achieve the physician-prescribed concentration of chemotherapy drugs or to flush the pump reservoir. Saline or heparinized saline (unless contraindicated) may be used during an interruption in chemotherapy to maintain pump and catheter patency. |
Code Information |
All SynchroMed EL and SynchroMed II pumps. |
Recalling Firm/ Manufacturer |
Medtronic Neuromodulation 800 53rd Ave NE PO Box 1250 Minneapolis MN 55440-1250
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For Additional Information Contact | 763-514-5174 |
Manufacturer Reason for Recall | Medtronic issued a letter to healthcare professionals providing important safety information regarding MRI (magnetic resonance imaging) effects on SynchroMed EL and SynchroMed II implantable infusion pumps. As stated in product labeling, the magnetic field of an MRI will temporarily stop the rotor of the pump motor and suspend drug infusion for the duration of MRI exposure for all SynchroMed pump |
FDA Determined Cause 2 | Labeling Change Control |
Action | An Urgent Medical Device Correction, Important Information on Potential MRI Effects letter, dated August 2008, was sent to health care professionals beginning August 25, 2008. The letter described the issue, provided patient management recommendations and included enclosures: Roller Study Procedure to confirm pump function, Post MRI Pump Interrogation Guidelines and New Information Regarding Potential MRI Effects. |
Quantity in Commerce | Approx 76,253 of all devices. |
Distribution | Worldwide Distribution --- USA including Washington D.C., and Puerto Rico, and countries of Algeria, Aruba, Austria, Belarus, Belgium, Croatia, Cyprus Czech Republic, Denmark, Egypt, Finland, France, French Polynesia, Germany, Greece, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy , Jordan Kuwait, Lebanon, Luxembourg, Malta, Netherlands, Netherlands Antilles, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia and Montenegro, Slovakia, Slovenia, Sough Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City State, New Caledonia, Brazil, Dominican Republic, Mexico, Hong Kong, Singapore, Canada, Australia and Japan. |
Total Product Life Cycle | TPLC Device Report |
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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.
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PMA Database | PMAs with Product Code = LKK
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