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U.S. Department of Health and Human Services

Class 2 Device Recall N'Vision software Application Card

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  Class 2 Device Recall N'Vision software Application Card see related information
Date Initiated by Firm March 23, 2009
Date Posted March 29, 2010
Recall Status1 Terminated 3 on July 10, 2012
Recall Number Z-1214-2010
Recall Event ID 54477
PMA Number P860004 
Product Classification pump, infusion, implanted, programmable - Product Code LKK
Product Medtronic N'Vision 8870 Application Card for use in the Medtronic model 8840 Physician Programmer. Manufactured for: Medtronic, Inc., Minneapolis, MN 55432-5604 USA.
Code Information All model 8870 application cards version AAG, AAJ (English only US & Japan) & BBG (Multi-Language OUS)
Recalling Firm/
Manufacturer		 Medtronic Neuromodulation
7000 Central Ave NE
Minneapolis MN 55432-3568
For Additional Information Contact
763-526-9684
Manufacturer Reason
for Recall		 Routine monitoring of Medtronic's vigilance program identified user related programming errors. Medtronic has received reports of both overdose and underdose that were the result of programming use of SynchroMed implantable infusion pumps. These errors were most commonly associated with: --Priming Bolus Programming; and --Bridge Bolus Programming. Pump programming errors that result in overdos
FDA Determined
Cause 2		 Other
Action Medtronic is exchanging 8870 versions AAG, AAJ and BBG and replacing it with the updated versions AAH01 and BBH01. The updated versions contain user interface improvements to reduce the chance of user related programming errors when programming SynchroMed II and SynchroMed EL Infusion Pump system. A Medtronic "Medical Device Correction" letter was left behind for consignees. The letter was addressed to "Healthcare Provider" and was dated February 2009. The letter provided information regarding changes to the programming software used in SynchorMed Infusion System. For additional information, please contact your Medtronic Representative or Medtronic Neuromodulation Technical Services at 1-800-707-0933.
Quantity in Commerce 8499 US
Distribution All States in the US including DC. OUS: Austria Belgium Croatia Cyprus Czech Republic Denmark Estonia Faroe Islands Finland France French Polynesia Germany Greece Hungary India Ireland Israel Italy Kuwait Lebanon Malta Martinique Netherlands New Caledonia Norway Poland Portugal Reunion Russian Federation San Marino Saudi Arabia South Africa Spain Sweden Switzerland Turkey United Kingdom Vatican City State Canada Mexico Brasil
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LKK and Original Applicant = MEDTRONIC Inc.
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