The following document is a copy of a Press Release from Medtronic releated to the Class I Medical Device Recall of the Medtronic 8870 Software Application Card Version AAA 02.
URGENT: Medtronic Announces Nationwide, Voluntary Recall of Model 8870 Software Application Card
Version AAA 02
Used with the Model N’Vision™ Clinician Programmer
MINNEAPOLIS, Sept. 22, 2004 - Medtronic, Inc. (NYSE: MDT) today announced a voluntary recall that involves all Version AAA 02 Model 8870 software application cards in the U.S. that are used in conjunction with all Model 8840 N’Vision™ Clinician Programmers. This action has been classified by the Food and Drug Administration (FDA) as a Class I Recall. The FDA defines a Class I recall as a situation in which there is a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.
The recall is limited to the affected software application cards and does not include drug pumps or any other devices implanted in patients. Patients are not required to take any action as a result of this recall.
The affected software application cards were distributed from December 2002 until May 2004. Medtronic no longer distributes the affected versions of the software cards.
Medtronic became aware in August 2003 that some users had mistakenly entered a periodic bolus interval into the minutes field, rather than the hours field, potentially resulting in drug overdoses. Data entry errors have been related to seven serious injuries and two deaths. The previous model 8870 software application card did not provide a label for the hours/minutes/seconds fields; the new software has this labeling.
This issue is limited to programming the SynchroMed® and SynchroMed® EL pumps. Programming of the SynchroMed II pump is not affected by this recall because AAA 02 software does not interface with the SynchroMed II pump.
Medtronic developed replacement software for SynchroMed and SynchroMed EL that provides additional information and clarification of the time intervals designed to help the user mitigate the risk of this data entry error. The company is now voluntarily recalling the previous version (AAA 02) software and providing an upgraded version, AAD 02, at no charge to all clinicians using the Model 8840 N’Vision Clinician Programmer. In the United States, 3,218 affected software cards were distributed, and more than half of these cards already have been retrieved and replaced.
As part of the recall, Medtronic is recommending that clinicians always use the latest Model 8870 software application cards, AAD 02 in the U.S. Medtronic is reminding clinicians to pay particular attention to selecting the appropriate time field when entering time duration or time intervals before updating the pump. Medtronic is working with the FDA to ensure that all affected clinicians are notified of the issue.
The clinician programmers are computer-like, external controllers used to set and adjust drug dose or infusion rate. The programming is done upon initial implant of the pump, and approximately every two to three months thereafter when the pump is refilled.
Medtronic, Inc., headquartered in Minneapolis, is the world’s leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is www.medtronic.com.
Should you have any questions about this recall or how to order the new software application cards, please contact Medtronic at: 800-328-0810, ext. 88608. This line is staffed 24/7 and physician consult is available upon request. Outside the U.S., contact your local Medtronic representative.
Any statements made about the company’s anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 30, 2004. Actual results may differ materially from anticipated results.