Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized u

FDA device recall Z-3043-2011 · posted 2011-08-29 · Terminated

Recall details

Recalling firm

Medtronic, Inc. - Neuromodulation

Reason for recall

Medtronic is updating information regarding the potential for reduced battery performance that can lead to sudden loss of therapy in a small percentage of Medtronic Model 8647 SynchroMed II pumps that was communicated with Healthcare providers in July 2009. The purpose of the current communication is to provide updated information regarding the scope and occurrence of this issue and to emphasize

Action taken

Medtronic Neuromodulation notified physicians with an Urgent Medical Device Correction letter beginning July 05, 2011. A press was issued July 08, 2011. The letter described the issue, severity, recommendations if they notice issue, and patient management recommendations. UPDATE: in November 2011, MDT began to exchange unused pumps in inventory with pumps that contained the new battery. A letter dated November 2011 was left behind at locations in which the MDT representative swapped out the devices.

Root cause

Component design/selection

Status

Terminated

Product code

LKK

Quantity affected

139,653 (105,002 US, 34,61 OUS)

Distribution

Worldwide including USA, Puerto Rico, Algeria, Aruba, Australia, Austria, Belarus, Belgium, Brazil, Chile. Colombia. Costa Rica. Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Fi

Date initiated

2011-07-05

Date posted

2011-08-29

Date terminated

2012-08-24

Location

Minneapolis, MN