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Medtronic Recalls Several Defective Products
March 21, 2008

FDA and Medtronic notified physiatry and pain management healthcare professionals of the Class 1 recall of Medtronic Neuromodulation Implantable Infusion Pumps, implantable devices for administering drugs to a specific site in the body to treat pain, spasticity and cancer. The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. On January 16, 2008, Medtronic sent a letter to doctors who implant these devices and/or provide care to patients with the implanted device. The letter described the problem, patient risks, patient management, recommendations and next steps. Medtronicís representatives will complete a reply card to document their communication with each doctor regarding this recall, as well as asking the doctors to sign and return a reply card. Let's hope these letters were sent out in time.


Website: March 21, 2008

 
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