Recall Z-1147-2015 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Medtronic Neuromodulation
The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or muscles when connected to an extension and/or lead. The Medtronic InterStim II Neurostimulator, Model 3058, and Medtronic InterStim Neurostimulator, Model 3023, are parts of neurostimulation systems for InterStim Therapy
| Date | Jun 26, 2015 (initiated Jan 9, 2015) |
| Status | Terminated |
| Reason | Current labeling indicates that cycling improves device longevity in every programming scenario. However, enabling cycling at certain parameter settings may decrease the device battery longevity. With cycling enabled, longevity estimate displayed on the Model 8840Programmer may be inaccurate. |
| Root cause | Other |
| Action | Consignees were sent a Medtronic {Medical Device Correction" letter dated January 9, 2015. The letter was addressed to Healthcare Professional. The letter described the issue and the product involved in the the recall. The letter also listed the Occurrence of the problem and labeling update. A Physician Reply Form was included which requested consignees to return the form to Medtronics. For questions they can contact Medtronic Neuromodulation Technical Services at 1-8007070944 weekdays 7 am 6 pm Central time. A second "Physician Notification Confirmation Form" was included to be completed b |
| Quantity | 396,975 (258,805 USA, 138,170 OUS) |
| Distribution | Worldwide Distributon- USA( nationwide including DC and PR) and Internationally to Mexico and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.