Medtronic Side Effects
How can Medtronic Side Effects affect You? | PatientsVille.com
View and Submit Medtronic Side Effects
Your Medtronic Side Effect submission can play a very important role. Reporting your experience could help identify an unknown risk and inform other patients and health care professionals.
Record and Track Your Side Effects
It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.
Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Side Effects reported to FDA: 3. View Medtronic Adverse Reports
Reported hospitalizations: 1
Medtronic Drug Infusion Pumps: Recall - Intermittent or Permanent Pump Motor Stall
SynchroMed II Implantable
AUDIENCE: Risk Manager, Physical Medicine, Neurosurgery
ISSUE: FDA and Medtronic notified healthcare professionals that using unapproved drugs with the SynchroMed Infusion Pump may negatively impact the pump’s performance. The use of unapproved drugs can lead to intermittent or permanent pump motor stall and cessation of drug infusion. A cessation of drug infusion may cause serious adverse health consequences, including death.
BACKGROUND: The SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps contain and administer prescribed drugs or fluids to a specific site inside the patient’s body. Currently, the approved drugs for use with the SynchroMed Infusion Pump are Infumorp, Lioresal, Prialt (Ziconotide), Floxuridine, Methotrexate and Gablofen.
These infusion pumps were manufactured from May 1998 through November 2012 and distributed from April 1999 through November 2012. Model numbers can be found in the recall notice.
RECOMMENDATION: To minimize the potential for motor stall, the firm recommended that healthcare professionals only use the approved drugs that are identified in the SynchroMed Infusion Pump labeling or drugs approved by FDA that are labeled for use with the SynchroMed II pump. Do not use compounded drugs, unapproved concentrations, or unapproved formulations with the SynchroMed Infusion Pump
Refer to the Medtronic Medical Device Safety Notification , sent November 9, 2012 to healthcare professionals, which includes detailed information about this issue. In addition to the Healthcare Professional Letter, the safety notification provided a white paper documenting the Increased Risk of Motor Stall and Loss of or Change in Therapy when Unapproved Drug Formulations are used with the SynchroMed Pump and a summary of the drugs that are approved to be used with the SynchroMed.
Medtronic Adverse Reactions
Anoxic Encephalopathy ( 1 Reports)|Cardiac Valve Replacement Complication ( 1 Reports)|Cardio-respiratory Arrest ( 1 Reports)|Coronary Artery Occlusion ( 1 Reports)|Coronary Artery Thrombosis ( 1 Reports)|Failure Of Implant ( 1 Reports)|Heart Valve Incompetence ( 1 Reports)|Hypoaesthesia ( 1 Reports)|Pain ( 1 Reports)|Post Procedural Complication ( 1 Reports)|Stent Occlusion ( 1 Reports)|