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General| Device Type | Implantable Infusion Pump |
|---|---|
| Reservoir Volume | 20 mL |
| Product Type | Programmable |
| Manufacturer | Johnson & Johnson (Codman) |
| Indication | Chronic pain, spasticity |
| Programmability | Yes |
| Infusion Modes | Continuous, Bolus |
| MRI Compatibility | MRI conditional |
| Intended Use | Intrathecal drug delivery |
Guidance on inserting the Touhy needle using fluoroscopy and a shallow, oblique paramedian insertion technique.
Procedure for advancing the needle until dura penetration and confirming intrathecal location via CSF backflow.
Details on removing the needle stylet, orienting the needle bevel, and threading the catheter distally.
Instructions for creating an incision centered at the needle insertion site to expose the fascia.
Procedure for placing a purse-string suture through the lumbo-dorsal fascia to secure the catheter.
Steps for carefully removing the needle tip, tightening the suture, and removing the guide wire simultaneously.
Methods to confirm catheter patency, including observing CSF backflow or saline injection.
Securing the catheter to the fascia using a silicone anchor and heavy non-absorbable suture.
Description of an alternative method using a cylindrical and right-angle silicone anchor for dual fixation.
Instructions for aseptically attaching the pump catheter to the pump's catheter port and securing it.
Steps for preparing the pump reservoir and bolus channel using the OR Prep Kit and instructions.
Guidelines on pump depth, incision placement to avoid septums, and refill port accessibility.
Technique for creating a subcutaneous pocket, emphasizing incision alignment and hemostasis.
Procedure for bending the tunneler and advancing it through the pump pocket wound to the catheter exit.
Instructions for removing the SNAPLOCK Adapter and threading the catheter through the tunneler.
Guidance on trimming the pump and intraspinal catheters to desired lengths and documenting volume.
Steps for inserting and tightening the SURESTREAM catheter into its connector.
Procedure for firmly securing the pump using heavy non-absorbable suture in the fascia.
Instructions for irrigating, closing incisions with sutures, and applying dressing.
Details the approved uses of the MEDSTREAM Programmable Infusion System for pain and spasticity management.
Lists conditions and patient factors where the system or its use is contraindicated.
Outlines the product's limited warranty and disclaims other implied warranties.
Specifies that the device is restricted to sale by or on the order of a trained physician.
Contact details for Johnson & Johnson MEDICAL GmbH, Geschäftsbereich Codman in Germany.
Contact details for Johnson & Johnson Medical SPA in Italy.
Contact details for Johnson & Johnson Medical Ltd in the United Kingdom.
Contact details for Codman & Shurtleff, Inc. in the USA.
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