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CODMAN® 3000 Constant Flow Pump MRI Information
Read and understand this document in its entirety prior to performing a Magnetic Resonance Imaging (MRI) procedure on a patient with an implanted CODMAN® 3000 Series Constant Flow Implantable Pump with Bolus Safety Valve. Failure to adhere to the conditions for safe use may result in serious injury to the patient. The CODMAN® 3000 Series Constant Flow Implantable Pump with Bolus Safety Valve is MR Conditional.
MRI SAFETY INFORMATION
Non-clinical testing has demonstrated that the CODMAN® 3000 Series Constant Flow Implantable Pump with Bolus Safety Valve is MR Conditional. A patient implanted with this device can be safely scanned in an MR system which meets or is operated under the following conditions:
- Static magnetic field of 1.5 Tesla or 3 Tesla, only
- Maximum spatial gradient magnetic field of 4,000 G/cm (40 T/m)
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2.0 W/kg
- Maximum gradient slew-rate (SR) of 150T/m/s per axis
WARNING: Exceeding the listed MRI Parameters could result in excessive force or torque, which could lead to patient injury.
Under the scanning conditions defined above, the CODMAN® 3000 Series Constant Flow Implantable Pump with Bolus Safety Valve is expected to produce a maximum temperature rise of less than 6.5°C after 15 minutes of continuous scanning. Scans longer than 15 minutes will require cooling delay periods equal in length to the exposure period to minimize risk of patient injury.
WARNING: A temperature increase of 6.5˚C may temporarily increase the flow rate by 90%. Please see the table below for the maximum volume that can be administered to a patient during a 15 minute MRI exposure for each Codman 3000 pump model.
WARNING: Consult with a physician to ensure that the patient can safely receive an increased dosage of the specific drug that is contained in the pump. The physician should calculate the exact drug dosage that will be administered during the MRI scan based on the concentration of the drug contained within the pump and the duration of the scan as determined by the MRI technician and/or radiologist. Please be aware, that the increased flow rate of the pump will persist until the pump has returned to body temperature. This may take up to 65 minutes/hours.
Note: In the event that the patient experiences uncomfortable warmth near the pump, the MRI scan should be stopped and the scan parameters should be adjusted to comfortable levels. If the patient CANNOT safely receive the increased dosage please empty the pump of all drug prior to the MRI or do not perform the MRI scan.
WARNING: MRI must be completed at a facility with resuscitative equipment and has proper drug reversal agents on hand. A physician must evaluate the patient immediately after MRI for signs and symptoms of drug overdose and develop a plan for immediate monitoring in a medically supervised and adequately equipped environment
A 6.5°C temperature increase will temporarily affect the flow rate as indicated below:
In non-clinical testing, the image artifact caused by the device extends less than 60mm from the CODMAN® 3000 Series Constant Flow Implantable Pump with Bolus Safety Valve when imaged with a gradient echo pulse sequence at 3.0T.
© CERENOVUS 2018
This site is published by CERENOVUS which is solely responsible for its contents. It is intended for visitors from the United States.
© CERENOVUS 2018 Last Updated on 12/21/2018
Important information: Prior to use, refer to the instructions for use supplied with this device for indications, contraindications, side effects, warnings and precautions.
Caution: US law restricts this device to sale by or on the order of a physician
As with any surgical procedure, the procedure to implant the CODMAN® 3000 Infusion Pump may present risks. Patients should consult with their doctors to discuss whether these types of procedures may be appropriate for them.