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Medtronic Side Effects

Common Medtronic Side Effects


The most commonly reported Medtronic side effects (click to view or check a box to report):

Medical Device Complication (1)
Stent Occlusion (1)
Pain (1)
Post Procedural Complication (1)
Cardio-respiratory Arrest (1)
Product Quality Issue (1)
Hypoaesthesia (1)
Heart Valve Incompetence (1)
Cardiac Perforation (1)
Cardiac Valve Replacement Complication (1)
Coronary Artery Occlusion (1)
Coronary Artery Thrombosis (1)
Failure Of Implant (1)
Anoxic Encephalopathy (1)


If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Medtronic Side Effects Reported to FDA

The following Medtronic reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Medtronic on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Cardiac Perforation, Medical Device Complication, Product Quality Issue
This is a report of a 74-year-old female patient (weight: NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Medtronic 5086 Mri Leads (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Cardiac Perforation
  • Medical Device Complication
  • Product Quality Issue
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Medtronic 5086 Mri Leads treatment in female patients, resulting in cardiac perforation side effect. The patient was hospitalized and became disabled.

Cardiac Valve Replacement Complication, Heart Valve Incompetence
This report suggests a potential Medtronic Mosaic Porcine Heart Valve Cardiac Valve Replacement Complication, Heart Valve Incompetence side effect(s) that can have serious consequences. A 84-year-old male patient (weight: NA) from UNITED STATES was diagnosed with the following symptoms/conditions: NA and used Medtronic Mosaic Porcine Heart Valve (dosage: NA) starting Jul 01, 2008. Soon after starting Medtronic Mosaic Porcine Heart Valve the patient began experiencing various side effects, including:
  • Cardiac Valve Replacement Complication
  • Heart Valve Incompetence
Drugs used concurrently: NA. Although Medtronic Mosaic Porcine Heart Valve demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as cardiac valve replacement complication, may still occur.

Anoxic Encephalopathy, Cardio-respiratory Arrest, Coronary Artery Occlusion, Coronary Artery Thrombosis, Post Procedural Complication, Stent Occlusion
This Anoxic Encephalopathy, Cardio-respiratory Arrest, Coronary Artery Occlusion, Coronary Artery Thrombosis, Post Procedural Complication, Stent Occlusion problem was reported by a health professional from UNITED STATES. A 59-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Mar 06, 2008 this consumer started treatment with Medtronic Endeavor Stent (dosage: NA). The following drugs were being taken at the same time: NA. When commencing Medtronic Endeavor Stent, the patient experienced the following unwanted symptoms/side effects:
  • Anoxic Encephalopathy
  • Cardio-respiratory Arrest
  • Coronary Artery Occlusion
  • Coronary Artery Thrombosis
  • Post Procedural Complication
  • Stent Occlusion
The patient was hospitalized and became disabled.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as anoxic encephalopathy, may become evident only after a product is in use by the general population.

Failure Of Implant, Hypoaesthesia, Pain
This is a report of a 35-year-old female patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: spinal osteoarthritis,cervicobrachial syndrome and was treated with Medtronic Premier Plate (dosage: NA) starting Dec 23, 2004. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Failure Of Implant
  • Hypoaesthesia
  • Pain
The patient was hospitalized and became disabled. This opens a possibility that Medtronic Premier Plate treatment could cause the above reactions, including failure of implant, and some female subjects may be more susceptible.



Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    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.


    Discuss Medtronic Side Effects

    Did You Have a Medtronic Side Effect?

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    Yes, Moderate
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    How Effective is Medtronic for You?

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    Effective
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    Medtronic Safety Alerts, Active Ingredients, Usage Information

    More About Medtronic

    Side Effects reported to FDA: 4

    Medtronic safety alerts: 2014 2013 2012 2011 2009 2008 2007 2006 2005 2004

    Reported deaths: 1

    Reported hospitalizations: 1

    Medtronic Drug Infusion Pumps: Recall - Intermittent or Permanent Pump Motor Stall

    SynchroMed II Implantable
    SynchroMed EL 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 disclaimer icon , 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.

    [12/21/2012 - Recall Notice - FDA]
    [11/09/2012 - Safety Notification disclaimer icon - Medtronic]

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