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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
on May 16, 2013 Female from US , 74 years of age, weighting 130.0 lb, was treated with Medtronic 5086 Mri Leads. Directly after, patient experienced the unwanted or unexpected Medtronic side effects: cardiac perforation, medical device complication, product quality issue. Medtronic 5086 Mri Leads dosage: N/A. Patient was hospitalized and became disabled.

Cardiac Valve Replacement Complication, Heart Valve Incompetence
Patient was taking Medtronic Mosaic Porcine Heart Valve. Patient felt the following Medtronic side effects: cardiac valve replacement complication, heart valve incompetence on Jul 08, 2008 from UNITED STATES Additional patient health information: Male , 84 years of age, weighting 194.4 lb, . Medtronic Mosaic Porcine Heart Valve dosage: N/A.

Anoxic Encephalopathy, Cardio-respiratory Arrest, Coronary Artery Occlusion, Coronary Artery Thrombosis, Post Procedural Complication, Stent Occlusion
Adverse event was reported on Apr 17, 2008 by a Male taking Medtronic Endeavor Stent (Dosage: N/A) . Location: UNITED STATES , 59 years of age, weighting 268.0 lb, After Medtronic was administered, patient encountered several Medtronic side effects: anoxic encephalopathy, cardio-respiratory arrest, coronary artery occlusion, coronary artery thrombosis, post procedural complication, stent occlusion. Patient was hospitalized and became disabled.

Failure Of Implant, Hypoaesthesia, Pain
on Jan 17, 2007 Female from UNITED STATES , 35 years of age, weighting 165.0 lb, was diagnosed with and was treated with Medtronic Premier Plate. Directly after, patient experienced the unwanted or unexpected Medtronic side effects: failure of implant, hypoaesthesia, pain. Medtronic Premier Plate dosage: N/A. Patient was hospitalized and became disabled.

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


    Track Online

  • User Sign In
  • Register to track your side effects

  • 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?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Medtronic for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    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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