The FDA and Medtronic notified healthcare
professionals of a Class I recall of all Medtronic Model
8870 software application cards, Version AAA 02, used
in conjunction with the Model 8840 N'Vision Clinician
Programmer. This software application card is used to
control the administration of medication of Synchromed
and Synchromed EL implantable infusion pumps. Several
pump infusion modes require the entry of a time duration
or interval. Medtronic has received reports of the entry
of hours into the minutes field, which has resulted in
deaths and injuries due to drug overdose.
Read the MedWatch 2004 safety summary, including a link
to the FDA recall notice, at:
http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#med8870
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Manufacturer's Recall Release:
URGENT: Medtronic Announces Nationwide, Voluntary Recall
of Model 8870 Software Application Card
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(tm)
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(r)
and SynchroMed(r) 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.
Updated September 15, 2004