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Medtronic Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Cardiac Valve Replacement Complication, Heart Valve Incompetence (5805353-5)
on Jul 08, 2008 Male from UNITED STATES , 84 years of age, weighting 194.4 lb, was treated with Medtronic Mosaic Porcine Heart Valve. Directly after, patient experienced the unwanted or unexpected Medtronic side effects: cardiac valve replacement complication, heart valve incompetence. Medtronic Mosaic Porcine Heart Valve dosage: N/A.

Anoxic Encephalopathy, Cardio-respiratory Arrest, Coronary Artery Occlusion, Coronary Artery Thrombosis, Post Procedural Complication, Stent Occlusion (5771259-3)
Patient was taking Medtronic Endeavor Stent. Patient felt the following Medtronic side effects: anoxic encephalopathy, cardio-respiratory arrest, coronary artery occlusion, coronary artery thrombosis, post procedural complication, stent occlusion on Apr 17, 2008 from UNITED STATES Additional patient health information: Male , 59 years of age, weighting 268.0 lb, . Medtronic Endeavor Stent dosage: N/A. Patient was hospitalized and became disabled.

Failure Of Implant, Hypoaesthesia, Pain (5235181-3)
Adverse event was reported on Jan 17, 2007 by a Female taking Medtronic Premier Plate (Dosage: N/A) was diagnosed with
  • spinal osteoarthritis
  • cervicobrachial syndrome
and. Location: UNITED STATES , 35 years of age, weighting 165.0 lb, After Medtronic was administered, patient encountered several Medtronic side effects: failure of implant, hypoaesthesia, pain. Patient was hospitalized and became disabled.

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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.

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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.

Medtronic Information

More About Medtronic

Side Effects reported to FDA: 3. View Medtronic Adverse Reports

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

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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