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Important Safety Information on Medtronic MiniMed Paradigm Insulin Infusion Pump - For Health Professionals
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(PDF Version - 40 K)The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.
This is duplicated text of a letter from Medtronic of Canada Ltd.
Contact the company for a copy of any references, attachments or enclosures.
May 11, 2007
Subject: Reminder to Avoid Exposing Medtronic MiniMed Insulin Pumps to Strong Magnetic Fields
Dear Health Care Professional,
PLEASE EMPHASIZE TO INSULIN PUMP USERS TO AVOID EXPOSING THE PUMP TO VERY STRONG MAGNETIC FIELDS SUCH AS MRI AND TO IMMEDIATELY DISCONTINUE PUMP USE IF THIS EXPOSURE OCCURS. THE INSULIN PUMP MUST BE REMOVED AND KEPT OUTSIDE THE PROCEDURE ROOM IF THE USER IS UNDERGOING MRI.
Recently, we have become aware of three potential cases outside of Canada where exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls the movement of the motor used in Medtronic MiniMed Paradigm® insulin infusion pumps. Although the pumps exhibited alarms as a result of this exposure it was reported that users overrode these alarms and continued to use the pump.
If the insulin pump is exposed to strong magnetic fields, the pump may exhibit over-delivery potentially resulting in severe hypoglycemia. As stated in the labeling the user must avoid exposing the pump to strong magnetic fields.
Medtronic has always stated in our labeling that users should avoid exposing infusion pumps to strong magnetic fields such as those associated with MRI machines. Until recently, all testing involving exposure of our Paradigm insulin pumps to these strong magnetic fields has indicated this exposure would result in significant damage and prevent Paradigm insulin pumps from delivering any insulin following this exposure. However, we are now aware that significant over-delivery of insulin can occur following this exposure under the conditions noted above.
In light of this new information, we are distributing the enclosed reminder to all Paradigm pump users to avoid exposing the pump to strong magnetic fields such as those associated with MRI procedures. Additionally, we are including similar information in the form of an insert that is included with all Paradigm pumps shipped to new customers or as replacement pumps for existing pump users.
Please note that Paradigm insulin infusion pumps have undergone extensive testing with devices such as airport metal detectors, electronic article surveillance equipment and cellular phones and we have confirmed that exposure to these devices will not adversely affect pump operation.
Please feel free to contact your Medtronic Diabetes support team at 1-800-284-4416 if you have any questions.
6733 Kitimat Road
Mississauga, Ontario L5N 1W3
Telephone: 905-826-6020
Fax: 905-826-6620
Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Tel: The Inspectorate Hotline 1-800-267-9675
The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada web site.
For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
E-mail: mhpd_dpsc@hc-sc.gc.ca
Tel.: 613-954-6522
Fax: 613-952-7738
Sincerely,
Original signed by
Ruth Pichora
Director, Diabetes
Medtronic of Canada Ltd.
