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Terminated

Medtronic Patient programmer, model 37742. The Patient programmer is a hand held, battery operated, microcontroller based device for use by patients to control and monitor external and implantable devices. The minimum amount of control involves the ability to tun therapy ON or OFF; maximal control allows the patient to select from different therapies and adjust the parameters with in the set therapy limits.

FDA Recall Z-2323-2008 · Posted 2008-09-20

Recalling FirmMedtronic Neuromodulation
Recall StatusTerminated
Product CodeLGW
Date Initiated2008-05-12
Date Terminated2008-11-21
Product Quantity2

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.

Firm Action

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

Distribution Pattern

GA, MO, NC, TX no OUS distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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