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; 7bit MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program FDA and Medtronic notified 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 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 28, 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. Medtronic's 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. Read the complete MedWatch safety summary, including links to the Recall Notice and the "Dear Healthcare Professional" letter, at: Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Buy onliner Preferences Page [ ]. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact This service is provided to you at no charge by U.S. Food & Drug Administration (FDA) [ ]. FDA [ ] HHS [ ] GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) . 5600 Fishers Lane . Rockville MD 20857 . 800-439-1420 ; =09MedWatch - Medtronic Neuromodulation Implantable Infusion Pumps: Class I recall - Reports of inflammatory mass formations =09 =09 =09 =09 body { =09font-size: 12px; =09font-family: arial, verdana, sans-serif; =09font-weight: normal; =09font-style: normal; } { =09color: gray; =09font-size: 10px; =09font-family: arial, verdana, sans-serif; =09font-weight: 100; } =09 =09 =09 =09 =09 =09 =09 =09 =09 =09FDA and Medtronic notified 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 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 28, 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. 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. Read the complete MedWatch safety summary, to the Recall Notice and the "Dear Healthcare Professional" letter, at: =09 =09 =09 =09 Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Buy onliner Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact This service is provided to you at no charge by U.S. Food & Drug Administration (FDA). =09 =09 =09 =09=09 =09 =09 =09 =09 =09=09 Inc. sending on behalf of U.S. Food & Drug Administration (FDA) 5600 Fishers Lane =09=09=09 Rockville MD 20857 800-439-1420 =09=09 =09 =09 =09

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