Recalls / —
—#72059
Product
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.
- FDA product code
- EZW — Stimulator, Electrical, Implantable, For Incontinence
- Device class
- Class 3
- Medical specialty
- Gastroenterology, Urology
- PMA numbers
- P970004S032
- Affected lot / code info
- serial numbers: NJD058707N, NJD062024N, NJD063259N, and NJD063324N
Why it was recalled
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.
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Medtronic Neuromodulation
- Address
- 800 53rd Ave NE PO Box 1250, Minneapolis, Minnesota 55440-1250
Distribution
- Distribution pattern
- GA, MO, NC, TX no OUS distribution
Timeline
- Recall initiated
- 2008-05-12
- Posted by FDA
- 2008-09-20
- Terminated
- 2008-11-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #72059. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.