Medtronic N'Vision 8870 Application Card for use in the Medtronic model 8840 Physician Programmer. Manufactured for: Medtronic, Inc., Minneapolis, MN 55432-5604 USA.
This recall has been terminated (originally issued March 29, 2010).
- Company
- Medtronic Neuromodulation
- Recall Initiated
- March 23, 2009
- Posted
- March 29, 2010
- Terminated
- July 10, 2012
- Recall Number
- Z-1214-2010
- Quantity
- 8499 US
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
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
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
Lot / Code Info
All model 8870 application cards version AAG, AAJ (English only US & Japan) & BBG (Multi-Language OUS)
Root Cause
Other
Action Taken
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.