Latest News for: synchromism

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Medtronic issues recall of some models of SynchroMed II drug pump

Star Tribune 17 Dec 2019
A manufacturing error in pumps made between May 2018 and April 2019 can cause the motor to jam ... .
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Medtronic SynchroMed II Pain Pumps Recalled

Public Technologies 30 Oct 2019
Medtronic SynchroMed II Pain Pumps Recalled ... The SynchroMed II pain pumps have stalled in some patients ... The voluntary recall included an urgent field notice to the medical community ... Patients who have the SynchroMed II pain pump should discuss the recall with their medical provider and report any complications with the devices ... Disclaimer ... (noodl.
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FDA Approves New SynchroMed II myPTM Personal Therapy Manager

Wireless Week 06 Nov 2018
Medtronic plc recently announced FDA approval of the new SynchroMed II myPTM Personal Therapy Manager for patients with chronic pain ... myPTM works with the SynchroMed II ...
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FDA Approves New SynchroMed(TM) II myPTM(TM) Personal Therapy Manager That Enables Patients to Alleviate Unpredictable Pain

Nasdaq Globe Newswire 24 Oct 2018
myPTM Allows Patients to Personalize Their Treatment by Delivering On-Demand Boluses, or Drug Doses, Within Therapeutic Limits Set by Their Physician ... .
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FDA Approves Innovative Clinician Programmer for the Medtronic SynchroMed II Intrathecal Drug Delivery System for Chronic Pain and Severe Spasticity

Public Technologies 10 Jan 2018
SynchroMed(TM) II for Chronic Pain Is an Alternative to Systemic Opioids for Many Patients ... Food and Drug Administration (FDA) approval of a new clinician programmer for use with the SynchroMed(TM)II Intrathecal Drug Delivery system, an implantable pump that provides targeted drug delivery for chronic pain and severe spasticity.
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Medtronic SynchroMed II implantable infusion pump

Public Technologies 11 May 2017
Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, has issued a new hazard alert for model 8637 SynchroMed II implantable infusion pumps manufactured before the end of June 2011 ... Original documenthttps.//www.tga.gov.au/alert/medtronic-synchromed-ii-implantable-infusion-pump-0.
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Medtronic SynchroMed II implantable infusion pump (TGA - Therapeutic Goods Administration)

Public Technologies 05 Dec 2016
Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, has issued an updated hazard alertfor the SynchroMed II implantable infusion pump regarding the known issue of over-infusion ... Original documenthttps.//www.tga.gov.au/alert/medtronic-synchromed-ii-implantable-infusion-pump.
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Medtronic SynchroMed II Infusion Pump Tied to 2 More Patient Deaths (Parker Waichman LLP)

Public Technologies 07 Nov 2016
Medtronic PLC is facing scrutiny over its SynchroMed II infusion pump, a pain pump that slowly delivers pain medication through a patient's spinal canal. The SynchroMed II infusion pump is used for conditions such as advanced metastatic cancer, chronic pain and severe spasticity ... The SynchroMed has raised safety concerns due to dosing errors.
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Medtronic Australasia - US consent decree on SynchroMed drug infusion system (TGA - Therapeutic Goods ...

Public Technologies 27 Jul 2015
Following the US consent decree described below, the TGA has imposed two new conditions on the inclusion of the SynchroMed II Programmable Pump in the Australian Register of Therapeutic Goods(link is external) (ARTG ID 97770) ... in relation to the SynchroMed drug infusion system.
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Medtronic Australasia - US consent decree on SynchroMed drug infusion system (TGA - Therapeutic Goods Administration)

noodls 28 May 2015
The TGA is aware of regulatory action undertaken by the US Food and Drug Administration (FDA) in relation to the SynchroMed drug infusion system ... The TGA will continue to monitor the safety and performance of SynchroMed drug infusion systems and will take appropriate regulatory action if a safety concern becomes apparent.
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FDA Medtronic must stop most sales of Synchromed drug pumps

Big News Network 28 Apr 2015
WASHINGTON -- The Food and Drug Administration says Medtronic must stop most sales of its implantable drug pumps after years of uncorrected problems.The FDA has filed a court order against Medtronic ... .
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Medtronic must stop most sales of Synchromed drug pumps

NZ Herald 27 Apr 2015
WASHINGTON (AP) " The Food and Drug Administration says Medtronic must stop most sales of its implantable drug pumps after years of uncorrected problems.The FDA has filed a court order against Medtronic that says the medical device... .
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FDA Enters Consent Decree with Medtronic (MDT) Over Synchromed II Pump Systems Manufacturing

StreetInsider 27 Apr 2015
Visit StreetInsider.com at http.//www.streetinsider.com/Corporate+News/FDA+Enters+Consent+Decree+with+Medtronic+%28MDT%29+Over++Synchromed+II+Pump+Systems+Manufacturing/10492381.html for the full story. .

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