Recall Z-2322-2008 ยท EZW Stimulator, Electrical, Implantable, For Incontinence
Medtronic Neuromodulation
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 se
| Date | Sep 20, 2008 (initiated May 12, 2008) |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| 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. |
| Quantity | 2 |
| Distribution | GA, MO, NC, TX no OUS distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.