Recall Z-0037-2008 ยท EZW Stimulator, Electrical, Implantable, For Incontinence
Medtronic Neuromodulation
Medtronic InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N'Vision with a Clinic an Programmer Model 8840. Implantable Neurostimulator for Urinary Control.
| Date | Oct 11, 2007 (initiated Jun 25, 2007) |
| Status | Terminated |
| Reason | A software issue may cause a lower than expected battery capacity estimate when evaluating an InterStim II Implantable Neurostimulator (model 3058) with an N'Vision Clinician Programmer(Model 8840) before implant . |
| Root cause | Software design |
| Action | Begining on July 11, 2007 a letter to the physicians was sent informing them of the issue and patient mangement of 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.