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[IPu] Fw: [IP] RE: Medtronic 8870 Recall



Hi All,
Just for info.  I don't believe this is being trialled here.
Janette
----- Original Message ----- 
From: "Crone" <email @ redacted>
To: <email @ redacted>
Sent: Saturday, September 25, 2004 4:45 AM
Subject: [IP] RE: Medtronic 8870 Recall


 From: CDER MEDWATCH LISTSERV
Date: 09/24/04 11:27:21
To: email @ redacted
Subject: FDA MedWatch - Class I Recall of Medtronic 8870 Software Applica
tion Card Version AAA 02


 MedWatch - The FDA Safety Information and Adverse Event Reporting Program

 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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