Recall Z-1192-2016 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
QiG Group LLC
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
| Date | Mar 18, 2016 (initiated Jan 26, 2016) |
| Status | Terminated |
| Reason | The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a connection to the external devices unless they were brought into close proximity (as close as 5 cm). The following functions may not be available: Reprogramming the stimulator, Adjusting stimulation parameters (on/off, intensity modifications, stimulation program selection), and Recharging the stimulator. |
| Root cause | Nonconforming Material/Component |
| Action | Consignee was sent on 1/26/2016 a Algostim, LLC "Urgent Field safety Notice" dated January 21, 2016. The letter described the problem and the product involved in the recall. The letter provided Background information as well as described the Clinical Implications, Rate of Occurrence, Recommendations and Mitigations. Advised consignee to deliver the respective letter to each physician who have implanted affected product and collect signed Response forms. |
| Quantity | 40 |
| Distribution | Distributed in Germany and Luxembourg. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.