Medtronic SynchroMed EL Programmable Pump, Model 8627-10. 10 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids.
Recall
- Recall Number
- Z-0587-2009
- Event Number
- 49603
- Firm
- Medtronic Neuromodulation
- FEI Number
- 2182207
- Product Code
- LKK
- Status
- Terminated
- Root Cause
- Labeling Change Control
- Initiated
- August 25, 2008
- Posted
- January 26, 2009
- Terminated
- May 17, 2012
- Address
- 800 53rd Ave NE PO Box 1250, Minneapolis, MN, 55440-1250
Description
Medtronic SynchroMed EL Programmable Pump, Model 8627-10. 10 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA. The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids.
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
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.
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.
Approx 76,253 of all devices.