Recall Z-1535-2021 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Medtronic Neuromodulation
Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators: Intellis with AdaptiveStim Technology Model 97715 Implanted Neurostimulator Intellis Model 97716 Implanted Neurostimulator.
| Date | Mar 25, 2021 |
| Status | Open, Classified |
| Reason | There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger. |
| Root cause | Under Investigation by firm |
| Action | Beginning 25-Mar-2021, Medtronic began notifying physicians in the US and consignees OUS via mail, email, fax, and/or personal visit by Medtronic personnel. In the US, each implanting physician was sent the medical device correction letter, the patient quick guide, and the customer confirmation form. Outside the US, the medical device correction letter, the patient quick guide, and the customer confirmation form were sent to the healthcare facilities. Additionally, on an ongoing basis, the patient quick guide will be provided with each replacement recharger. |
| Quantity | 79,616 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.