Company: Medtronic Neuromodulation
Date of Enforcement Report 10/22/2008
Class:lll
PRODUCT
a) Medtronic iCon Patient Programmer, model 3037. 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 turn therapy ON or OFF; maximal control allows the patient to select from different therapies and adjust the parameters with in the set therapy limits, Recall # Z-2322-2008;
b) 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, Recall # Z-2323-2008
REASON
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.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neuromodulation, Minneapolis, MN, by letters and visits beginning May 12, 2008.
Manufacturer: Benchmark Electronics Inc., Winona, MN. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
GA, MO, NC, TX
