Medtronic iCon Patient Programmer, model 3037. The Patient programmer is a hand held, battery operated, microcontroller

FDA device recall Z-2322-2008 · posted 2008-09-20 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

Medtronic is retrieving four (4) patient programmers that were not properly loaded with application software. The application software is needed for a patient programmer to synchronize and bond with a neurostimulation device. Without this functionality a patient programmer is not useable and can not communicate with a neurostimulation device.

Action taken

A letter was sent to each account telling them of the issue and to let them know that Medtronic is retrieving the affected devices. Medtronic Reps were to visit affected accounts to notify them of the recall, locate the affected device and return it. Rep is to complete the reply card and fax to Medtronic Neuromodulation. If you have questions, contact your Medtronic representative or Medtronic Neuromodulation Technical Services at 1-800-707-0933.

Root cause

Process control

Status

Terminated

Product code

EZW

Quantity affected

2

Distribution

GA, MO, NC, TX no OUS distribution

Date initiated

2008-05-12

Date posted

2008-09-20

Date terminated

2008-11-21

Location

Minneapolis, MN