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Urgent: Medical Device Correction Update - April 2017 Battery Performance of the Model 8637 SynchroMed ® II Implantable Drug Infusion PumpUpdate to the 2011 NotificationModels Affected:8637-20, 8637-40Description:This clinician communication provides an update to information previously communicated to physicians in July 2011 regarding the failure rate for reduced battery performance in Medtronic Model 8637 SynchroMed ® II pumps manufactured through June 2011. This notice reinforces previously communicated patient management recommendations related to this issue.Reduced battery performance impacts battery voltage, which can prematurely activate the pump Elective Replacement Indicator (ERI), End of Service (EOS), and/or cause a Low Battery Reset. 2016 URGENT: MEDICAL DEVICE CORRECTION – SEPTEMBER 2016UPDATE TO MODEL 8870 SOFTWARE APPLICATION CARD USED IN THE 8840 N’VISION CLINICIAN PROGRAMMER AND SYNCHROMED TM INFUSION SYSTEM LABELING FOR PRIMING BOLUSModels Affected:8637-20, 8637-40 SynchroMed Infusion System8840 Clinician Programmer8870 Software Application CardDescription:This notification is a follow up to the May 2013 communication regarding the SynchroMed II priming bolus function. Medtronic is updating the Model 8870 software application card as well as the SynchroMed Infusion System labeling to mitigate the risk of the potential for clinically relevant effects of over-delivery of unintended drug during the full system priming bolus procedure. The SynchroMed priming bolus function is intended to quickly advance drug from the pump reservoir to the catheter tip to allow for therapy initiation while the patient remains under medical supervision. Read on for detailed information related to this communication. URGENT: MEDICAL DEVICE CORRECTION UPDATE– SEPTEMBER 2016UPDATE TO THE MARCH 2014 COMMUNICATION ON SYNCHROMED II OVERINFUSIONModels Affected:8637-20, 8637-40 SynchroMed II Implantable Drug Infusion PumpDescription:This communication is an update to Medtronic's March 2014 notification regarding the potential for SynchroMed II pump overinfusion.
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This notification updates information related to contributing causes, occurrence rate and patient management recommendations. Consistent with the previous communication, Medtronic is not retrieving SynchroMed II pumps from the field or recommending prophylactic replacement of the pumps. 2015 Urgent Medical Device Correction – April 2015SynchroMed II Implantable Drug Infusion Pump Audible AlarmModels Affected:8637-20, 8637-40This physician communication provides important information regarding a potential malfunction of the audible alarm of a finite subset of Model 8637-20 and 8637-40 SynchroMed II implantable drug pumps (based on serial number). The cause of this issue has been addressed, and therefore only products identified by this notification are potentially affected. Medtronic is not recommending prophylactic replacement of pumps due to the low projected rate of occurrence of this issue.This communication is based on information available to date and was developed in collaboration with clinical experts. Read on for detailed information related to this communication.
2014 Urgent: Medical Device Correction – March 2014SynchroMed II Implantable Drug Infusion Pump OverinfusionModels Affected:8637-20, 8637-40This physician communication provides important new information regarding overinfusion associated with the SynchroMed II Implantable Pump. Overinfusion can result in a life-threatening overdose and can also result in drug withdrawal due to premature emptying of the pump. Due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk, Medtronic is not recommending prophylactic replacement of pumps. This communication is based on information available to date and was developed in collaboration with clinical experts. Read on for detailed information related to this communication. Urgent: Medical Device Removal – May 2013 Sutureless Connector Intrathecal Catheter ProductsAffected Products:Models: 8709SC, 8731SC, 8596SC, 8578 (with Use by Date prior to 25 Aug 2014)The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing unused products from the market that were manufactured with the previous design, and recommends the previous design no longer be used due to greater potential for misalignment and subsequent occlusion.Refer to the customer letter for details regarding this Urgent Medical Device Removal.
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2012 Medical Device Safety Notification – November 2012Use of Unapproved Drugs with the SynchroMed Implantable Infusion PumpAffected Products:SynchroMed II and SynchroMed ELThis clinician communication provides updated information on Medtronic Neuromodulation's continuing efforts to investigate and communicate the impact of unapproved drugs on the performance of the SynchroMed infusion pump system. Use of unapproved drugs with the SynchroMed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion.Read on for detailed information related to this communication.
2011 Urgent: Medical Device Correction - July 2011Model 8637 SynchroMed II Battery PerformanceUpdate to the 2009 CommunicationModels Affected:8637-20, 8637-40This clinician communication provides updated information regarding the scope and occurrence of the SynchroMed II Battery Performance issue that was previously communicated in July 2009.Reduced battery performance impacts battery voltage, which can prematurely activate the pump Elective Replacement Indicator (ERI), End of Service (EOS), and/or cause a Low Battery Reset.Read on for detailed information related to this communication. 2009 Medical Device Correction – August 2009Sutureless Connector (SC) Intrathecal Catheters Are Not Compatible with IsoMed Constant–Flow Infusion PumpsThis communication provides important safety information regarding Medtronic Sutureless Connector (SC) intrathecal catheters and revision kits (SC catheters).The current SC catheter labeling incorrectly states that SC catheters are compatible with Medtronic IsoMed constant-flow infusion pumps. SC catheters are not compatible with IsoMed pumps.SC catheters are compatible with Medtronic SynchroMed II and SynchroMed EL pumps. 2008 Medical Device Correction - August 2008Important Information on Potential MRI EffectsThis communication provides new safety information related to MRI (magnetic resonance imaging) effects that may impact pump performance.
As stated in the product labeling for all SynchroMed pumps, the magnetic field of an MRI scan will temporarily stop the rotor of the pump motor and suspend drug infusion for the duration of MRI exposure.The pump should resume normal operation when removed from the MRI magnetic field; however, the following is new information:. There is the potential for a delay in the return of proper drug infusion after an MRI scan (this affects all SynchroMed pumps). Freepbx install unistim decoder. There is the potential for a delay in the logging of motor stall events after an MRI scan (this only affects SynchroMed II pumps).
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Medical Device Safety Alert - June 2008Proper Connection of Sutureless Connector Intrathecal CathetersThis safety alert provides important safety information concerning potential disconnection of the Medtronic sutureless connector ('SC') catheters from the catheter port on the pump, or occlusion between the sutureless pump connector and the catheter port on the pump. Please note that this issue does not involve Medtronic MiniMed insulin pumps.Medtronic has received reports of infusion system difficulties that have been attributed to occlusion between the sutureless pump connector and the catheter port, and disconnections of the sutureless pump connector from the catheter port. Medtronic investigation indicates these events are caused by misalignment or incomplete connection of the sutureless pump connector to the catheter port. Proper alignment and full engagement of the sutureless pump connector to the catheter port during attachment is critical in ensuring the catheter is properly and completely connected to the pump. 2007 Medical Device Correction – August 2007SynchroMed EL Pump Motor Stall Due to Gear Shaft WearThis communication provides important information about a pump motor stall issue that affects SynchroMed EL pumps with motors manufactured prior to September 1999. This population of pumps can stall at a higher rate due to gear shaft wear.If a pump motor stall occurs, drug delivery will stop abruptly and without warning resulting in loss of therapy, return of underlying symptoms, and/or symptoms of drug underinfusion or withdrawal. The SynchroMed EL pump does not provide an alarm to alert the patient or clinician to a stalled motor condition.
Drug withdrawal from ITB Therapy can be fatal if not treated promptly and effectively. 2006 Educational Brief – November 2006Patient Mortality after Implant and Initiation of Intrathecal Infusion Therapy for PainThe purpose of this communication is to provide information for reducing the risk of death or serious injury after initiation of intrathecal infusion therapy for pain. Medtronic has received reports of patient deaths occurring soon after the implant or revision of a SynchroMed system. The available evidence indicates the infusion systems operated normally and device malfunction was not the cause of these adverse events.
Hilary Stokes says that we have trillions of brain cells, resulting inthousands (if not millions) of strings of lights (chemical reactions) correlating with our habitsin all areas of our life.In part one, the introduction, we looked at why we need to explore the ideaof rewiring the brain. In my opinion I want to be able to get out of depressioneasier and cope better with anger, stress and anxiety. I want to let go of unhealthybehaviors. The idea is to make me healthier so that I can be more productive,approachable and calmer.I want to get out of the victim role where there is blame and disadvantage andinto the creator role where I use my circumstances to my advantage to controlmy present destiny.I was captivated by an article titled'.It's about activating neuro pathways to create new neural networks in the brain.My article is a summary of the original for documentation purposes and adaptationof my understanding of the content as best I can.Activate pathwaysDr. Hilary Stokes wrote that Neuroscientists have discovered the strategy forrewiring the brain.
According to her post five neuro pathways must be activatedin order to create new neural networks in the brain. Identify the beliefs that support your intentionYou need to believe that it is actually possible to change your behaviorin a certain way. If you don't believe it is possible, you cannot change. What are your beliefs regarding the particular behavior?. Identify the beliefs that make it possible to change your behavior. Make these beliefs your intention.Example: When someone is questioning Jane, she gets defensive because shefeels interrogated and makes her feel threatened.
Those are her beliefs.She could identify that not all questions are interrogations and that shedoesn't have to feel threatened.She can use this to her advantage and as her intention to not get defensivethe next time she is questioned but she must believe it. Embrace your strong positives emotionsNeutral emotions don't have enough power to induce change. If you are feelinga strong enough emotion, use it as fuel to change your behavior. What emotions do you feel that drive the need to change your behavior?.
Why is this meaningful to you?. Spend time with the emotion while you focus on your intention.Example: Jane feels embarrassed by her defensive reaction. She gets angry,lashes out which only results in negative responses back at her.It's meaningful to her to change her behavior because she wants to be moreapproachable, calm and relaxed in a conversation.She can reflect on this meaning with her emotions so that she can reinforceher intention. VisualizeYour brain is awesome but filled with trickery. Imagination can become reality.You can use this to your advantage to train your brain into new habits bymentally rehearsing them.
This strengthens the ability to form new habits. What imagery aligns with changing your behavior?.
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Visualize them dailyExample: Jane could imagine being questioned by a colleague. She could imaginedifferent types of questioning styles specifically the ones that make herdefensive.She could visualize scenes where she responds to these questions in a moreapproachable manner.
Take actions that support your intentionYour behavior must align with your vocabulary. You need to fully believeyour actions. You need to identify what actions are aligned with yourthoughts and emotions.Example: Jane cannot say that she will be approachable but when asked questionsbecome defensive. Her behavior must mimic her intention through practice.If she gets it wrong, she can reflect and introspect to determine what sheneeds to do to get it right.
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