Recall Z-0040-2008 ยท EZW Stimulator, Electrical, Implantable, For Incontinence
Medtronic Neuromodulation
Medtronic InterStim INS (Model 3023) with N'Vision Inter Stim-B software supplied on the Model 8870 Version MMB_01/NNB_01 with N'Vision Clinician Programmer Model 8840 or InterStim iCon Patient Programmer Model 3037. Implantable Neurostimulator for Urinary Control.
| Date | Oct 12, 2007 (initiated Jun 25, 2007) |
| Status | Terminated |
| Reason | Software issue may cause false low battery alert to be displayed when interrogating an Interstim Implantable Neurostimulator (Model 3023) with an N'Vision Clinician Programmer (Model 8840), or with an Inter Stim iCon Patient Programmer (Model 3037). |
| Root cause | Software design |
| Action | Begining on July 11, 2007 a letter to the physicians was sent informing them of the issue and patient management for the two issues. The letter includes a Cover Letter, A Reply Form, and two Recall letters explaining the issue in detail. |
| Quantity | 1885 |
| Distribution | Nationwide and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.