SynchroMed II pump and catheter are part of an implantable, programmable drug infusion system that stores and delivers medication into the intrathecal space. In their analysis, the authors found that the Ascenda catheter can reduce major complications related to the catheter after ITB pump implantation. Cause 2 Nonconforming Material/Component FDA Determined Further investigation is necessary to expand on and confirm their results. Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 00643169202139 (c) 8784, UDI: 00643169202153 The Ascenda Intrathecal Catheter kits (models 8780, 8781 and 8784) contain parts of an infusion system that delivers drugs to the intrathecal space. Medtronic is removing specific lots of the Ascenda Intrathecal Catheters and Revision Kits, which are used with the implantable SynchroMed drug infusion pump. Medtronic Neuromodulation Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. The drug enters the pump through the reservoir fill port and passes through the reservoir valve and into the SynchroMed™ II pump reservoir. This website also uses Open Source Software (OSS) provided by
Barbosa D, Assumpçao de Mônaco B, Talamoni Fonoff E. Intrathecal morphine therapy Medtronic's medical therapies treat cardiac and vascular diseases, diabetes, and neurological and musculoskeletal conditions. You may at any time change the settings regarding cookies. J Neurosurg Pediatr. Medtronic is removing specific lots of the Ascenda Intrathecal Catheters and Revision Kits, which are used with the implantable SynchroMed drug infusion pump. There are multiple tests performed on the Ascenda catheter system by Medtronic as part of their design verification process. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.Medical technologies transform the world! This recall is being conducted due to a single component of the catheter, the retainer ring, not meeting specification criteria. The letter described the issue, identified affected product, provided patient management recommendations for patients implanted with an affected device, asked for Risk Management to quaratine unused inventory within the hospital, and to contact Medtronic Customer Service at 1-888-638-7627 to facilitate return of devices. Pump segment with attached sutureless pump connector; ... Medtronic is the world’s largest medical technology company, offering an unprecedented breadth and depth of innovative therapies to fulfill the Mission of alleviating pain, restoring health, and extending life. Except where otherwise noted, content on this wiki is licensed under the following license: At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004. The SynchroMed II pump is implanted below the skin and the Ascenda Catheter snakes from the device to the intrathecal space that surrounds the spinal cord. PubMed PMID: 25896138.
Price: $119.00 per box of 1 Quantity: In Stock: 11 box of 1: Status: expired: The peristaltic action of the SynchroMed™ II pump moves the drug from the pump reservoir, through the pump tubing, check valve, catheter port, and implanted catheter, to the infusion site. This recall is being conducted due to a single component of the catheter, the retainer ring, not meeting specification criteria. Medtronic has announced the upcoming launch of its silicone Ascenda Catheter for use with the company's SynchroMed II programmable baclofen injection Christopher Reis, D.O. Medtronic is the world’s largest medical technology company, offering an unprecedented breadth and depth of innovative therapies to fulfill the Mission of alleviating pain, restoring health, and extending life. MEDTRONIC Inc. 7000 central avenue ne: minneapolis, MN 55432-3576: PMA Number: P860004: Supplement Number: S266: ... Reorient the spinal segment catheter and the spinal segment catheter revision kit within the Ascenda Catheter Assembly (Model 8780) and the Ascenda Catheter Revision Kit Assembly (Model 8782) sterile packages. Drug injected into the CAP bypasses the SynchroMed™ II pump mechanism and goes directly through the catheter port into the implanted catheter to the infusion site. Medtronic is the world’s largest medical technology company, offering an unprecedented breadth and depth of innovative therapies to fulfill the Mission of alleviating pain, restoring health, and extending life. Why recommend targeted drug delivery? The item listed above is expired and may be used for educational, training, and non-clinical research purposes only.
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