Safety Information on Certain Models of Medtronic Implantable Cardiac Defibrillators – Medtronic of Canada Ltd. – For Health Professionals

Health Canada Endorsed Important Safety Information on Medtronic Implantable Cardiac Defibrillators, Marquis ICD and CRT-D

February 2005

Subject: Association of Medtronic Implantable Cardiac Defibrillators, Marquis ICD and CRT-D with rapid battery depletion

Dear Health Care Professional,

We are advising you about Medtronic Marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism.

As a part of ongoing returned product analysis, Medtronic has received nine (9) units from the above population (approximately 1 in 10,000) that have exhibited this mechanism. There have been no reported patient injuries or deaths due to this issue.

The purpose of this communication is to inform you that highly accelerated bench testing indicates that the rate of this shorting mechanism may increase as the battery is depleted. While the current rate is 1 in 10,000 (0.01%), bench test data indicates this rate may increase to between 0.2% and 1.5% over the second half of device life. We will provide you regular updates on the ongoing actual performance every six months in our Product Performance Report.

Devices manufactured with batteries produced after December 2003 are not affected. Specific battery design changes were implemented in December 2003 that eliminates the possibility of this internal shorting mechanism. Although there were no field returns for this issue at that time, these design changes were made based on engineering testing and analysis.

There is no provocative testing that predicts which of these devices will experience this issue. Once a short occurs, depletion can take place within a few hours to a few days, after which there is complete loss of device function. It is also possible that as the battery depletes quickly, patients may experience temporary warmth in the area surrounding the ICD.

The specific model and serial numbers of affected devices sold to or on consignment at your hospital in your practice are attached to this letter.

We recommend you consider the following patient management options:

• Conduct quarterly (i.e., every three months) follow-up procedures.
• Inform patients that should they experience warmth in the area surrounding the ICD to seek follow-up care promptly.
• Program Low Battery Voltage ERI Patient Alert™ to "On-High". This will result in an audible, alternating tone in the limited circumstances where a battery depletes slowly over a number of days. Data indicates most shorts will occur rapidly and will not be detected by this feature.
• Provide a handheld magnet to patients to check device status and program the Low Battery Voltage ERI Patient Alert™ to "On-High". Device operation may be monitored periodically (e.g., daily) by patients placing the magnet over the device for 1-2 seconds. If the device is functional, a steady tone will sound for approximately 20 seconds. If no tone is heard, follow-up care should be sought promptly.

Should you decide to replace an affected device in a specific patient (e.g., a patient who is pacemaker dependent or receives frequent VT/VF therapy), Medtronic will provide a device at no cost.

Your Medtronic representative will evaluate and replace any inventory in your center(s) affected by this action.

Medtronic is communicating this information to the appropriate regulatory agencies.

The identification, characterization, and management of medical device-related adverse incidents are dependent on the active participation of health care professionals in adverse incident reporting programmes. Any occurrences of rapid battery depletion or other serious and/or unexpected adverse incidents in patients with Medtronic ICD and CRT-D devices should be reported to Medtronic of Canada Ltd. or Health Canada at the following addresses:

Medtronic of Canada Ltd.

6733 Kitimat Road

Mississauga, ON L5N 1W3

Health professionals may contact their sales representative at 1-800-268-5346

Any suspected adverse reaction can also be reported to:

Health Products and Food Branch Inspectorate

HEALTH CANADA

Address Locator: 3002C

Ottawa, Ontario K1A 0K9

Tel: The Inspectorate Hotline 1-800-267-9675.

For other inquiries: please refer to contact information.

MHPD_DPSC@hc-sc.gc.ca

Tel/Tél : (613) 954-6522

Fax/Télé : (613) 952-7738

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada web site.

We regret the difficulties this causes you and your patient(s). If you have questions, or if we can be of further assistance, please contact your local Medtronic representative.

Sincerely,

original signed by

David Cameron

Vice-President, Medtronic of Canada Ltd.