Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spin

FDA device recall Z-0124-2014 · posted 2013-10-31 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

Medtronic notified customers regarding over stimulation or stimulation in the wrong area related to select Medtronic neurostimulators. Upon a specific set of conditions, typically related to device recovery from an over discharge, there is a potential for over stimulation or stimulation directed to a lead electrode other than what was intended.

Action taken

The firm, Medtronic, sent an "Urgent: Medical Device Correction" letter dated September 2013 entitled "Loss of Stimulation and Over Stimulation" to customers associated with the affected Medtronic neurostimulators. This letter described the product, problem and actions to be taken. The letter informed customers of the potential for these issues to occur and provided recommendations to significantly reduce the likelihood of the issues. The customers were instructed to avoid over discharge; if a rechargeable device becomes over discharged, contact Medtronic Patient Services at (1-800-510-6735) to resolve the POR and reduce the likelihood of over stimulation. If you have questions, please contact Medtronic Neurostimulation Technical Services at 1-800-707-0933 weekdays 7am-6pm CST.

Root cause

Software design

Status

Terminated

Product code

LGW

Quantity affected

64,163

Distribution

Worldwide distribution: US (Nationwide) including Puerto Rico and countries of: Algeria, Aruba, Austria, Belarus, Belgium, Brazil, Bulgaria, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republi

Date initiated

2013-09-30

Date posted

2013-10-31

Date terminated

2015-11-20

Location

Minneapolis, MN