Recall Z-1600-2016 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Nuvectra
Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Stimulation Systems. The version of the software in the Clinician Programmer is v1.1.5. The Algovita Spinal Cord Stimulation system consists of a stimulator (EPG or IPG) that is physically and electrically connected to one or more leads inserted into the patient"s spinal epidural
| Date | May 3, 2016 (initiated Apr 6, 2016) |
| Status | Terminated |
| Reason | If used, the optional Swap feature copies programming parameters from the external pulse generator (EPG) as well as unintended calibration data to the implantable pulse generator (lPG). This may result in the user being unable to recharge the lPG. This safety notice only applies to CPs Model 4500. |
| Root cause | Software design |
| Action | Nuvectra sent an "Urgent Field Safety Notice" letter dated April 6, 2016 to customers. The letter identified the affected product, problem, recommendations and Mitigations, and actions to be taken. |
| Quantity | 17 OUS |
| Distribution | Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.