Medtronic N'Vision 8870 Application Card for use in the Medtronic model 8840 Physician Programmer. Manufactured for: Med

FDA device recall Z-1214-2010 · posted 2010-03-29 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

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

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.

Root cause

Other

Status

Terminated

Product code

LKK

Quantity affected

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 Ku

Date initiated

2009-03-23

Date posted

2010-03-29

Date terminated

2012-07-10

Location

Minneapolis, MN