The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of

FDA device recall Z-1147-2015 · posted 2015-06-26 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

Current labeling indicates that cycling improves device longevity in every programming scenario. However, enabling cycling at certain parameter settings may decrease the device battery longevity. With cycling enabled, longevity estimate displayed on the Model 8840Programmer may be inaccurate.

Action taken

Consignees were sent a Medtronic {Medical Device Correction" letter dated January 9, 2015. The letter was addressed to Healthcare Professional. The letter described the issue and the product involved in the the recall. The letter also listed the Occurrence of the problem and labeling update. A Physician Reply Form was included which requested consignees to return the form to Medtronics. For questions they can contact Medtronic Neuromodulation Technical Services at 1-8007070944 weekdays 7 am 6 pm Central time. A second "Physician Notification Confirmation Form" was included to be completed by Medtronic Representatives.

Root cause

Other

Status

Terminated

Product code

LGW

Quantity affected

396,975 (258,805 USA, 138,170 OUS)

Distribution

Worldwide Distributon- USA( nationwide including DC and PR) and Internationally to Mexico and Canada

Date initiated

2015-01-09

Date posted

2015-06-26

Date terminated

2017-09-28

Location

Minneapolis, MN