10,000 results
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114ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INDURA LKK
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code LKK·January 3, 2007
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·June 20, 2008
SYNCHROMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·June 20, 2008
N'VISION
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·September 21, 2007
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code LKK·September 21, 2007
INDURA
FDA Adverse Event
Injury
·RICE CREEK MANUFACTURING·Product code LKK·September 21, 2007
INDURA CATHETER
FDA Adverse Event
Malfunction
·RICE CREEK MANUFACTURING·Product code LKK·September 21, 2007
SYNCHROMED EL
FDA Adverse Event
Malfunction
·RICE CREEK MANUFACTURING·Product code LKK·September 21, 2007
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 19, 2016
The Model 8540 Catheter Access Port Kit is intended for use in accessing the catheter via the catheter access port of Medtronic(R) implantable programmable infusion pumps (except Medtronic MiniMed pumps). The Model 8540 Catheter Access Port Kit does not have a product code for itself; it is approved under PMA P860004. PMA P860004 is classified as: pump, infusion, implanted, programmable under product code LKK.
FDA Recall
Terminated
·Medtronic Inc, Neurological & Spinal Division·Product code LKK·July 23, 2004
Model 8561 Lioresal (Baclofen injection) Intrathecal Refill Kit is designed for refilling the Medtronic SynchroMed family of pumps. The 8561 kit contains a 1-20 ml ampule of 500 mcg/ml Baclofen injection along with a sterile refill kit tray and sterile drug preparation tray. Lioresal drug ampules contained witin Medtronic Lot N0016487 bear the primary manufacturer''s label and lot number 007J2583. The drug box is labeled with Lot 017H1925. Medtronic packages a manufacturer''s labeled ampule into a protective drug box. A lot number and drug lot expiration date are printed on the outside of the drug box. The filled and labeled drug box is placed inside a larger kit assembly that contains other components necessary to complete a pump refill. Only the large kit assembly (''Lioresal Refill Kit'') will display the Medtronic lot number (N0016487). The Model 8561 refill kit does not have a product code for itself; it is approved under PMA P860004. PMA P860004 is classified as: pump infusion, implanted, programmable under product code LKK.
FDA Recall
Terminated
·Medtronic Inc, Neurological & Spinal Division·Product code LKK·November 19, 2004
Pump, Infusion, Implanted, Programmable
FDA classification
FDA Class 3
·Pump, Infusion, Implanted, Programmable
Medtronic SynchroMed EL Programmable Pump, Model 8626L-18. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.--(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)
FDA Recall
Terminated
·Medtronic Neuromodulation·Product code LKK·August 3, 2007
Medtronic SynchroMed EL Programmable Pump, Model 8627-10. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.--(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)
FDA Recall
Terminated
·Medtronic Neuromodulation·Product code LKK·August 3, 2007
MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market.
FDA Recall
Terminated
·Codman & Shurtleff, Inc.·Product code LKK·November 10, 2015
Medtronic SynchroMed EL Implantable Infusion Pump, model 8627L-18. The contents of the inner package have been sterilized by ethylene oxide gas. 18 mL pump with reservoir valve, screened side catheter access port and suture loops. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. 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.
FDA Recall
Terminated
·Medtronic Neuromodulation·Product code LKK·January 16, 2008
Medtronic SynchroMed EL Implantable Infusion Pump, model 8627-18. The contents of the inner package have been sterilized by ethylene oxide gas. 18 mL pump with reservoir valve and screened side catheter access port. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. 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.
FDA Recall
Terminated
·Medtronic Neuromodulation·Product code LKK·January 16, 2008
Medtronic IsoMed Implantable Constant-Flow Infusion Pump, model 8472-35. The contents of the inner package have been sterilized by ethylene oxide gas. Reservoir size: 35 mL. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. The implantable Medtronic IsoMed Constant-Flow Infusion Pump is part of the IsoMed Constant-Flow Infusion System designed to contain and administer parenteral drugs to a specific site. The components of the IsoMed Constant-Flow Infusion System include the pump, Medtronic catheter, catheter accessories, Medtronic Refill kit, and Medtronic catheter access port kit. IsoMed pumps are implantable devices that store and dispense drugs according to a constant flow rate set during the manufacturing process.
FDA Recall
Terminated
·Medtronic Neuromodulation·Product code LKK·January 16, 2008
Model 8731SC Intrathecal Catheter Medtronic Inc., Minneapolis, MN 55432 A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy.
FDA Recall
Terminated
·Medtronic Neuromodulation·Product code LKK·April 14, 2008
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 Recall
Terminated
·Medtronic Neuromodulation·Product code LKK·March 12, 2012