Recall Z-2036-2023 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Medtronic Neuromodulation
Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
| Date | Jun 29, 2023 (initiated Jun 6, 2023) |
| Status | Open, Classified |
| Reason | A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total of two complaints concerning this issue from patients implanted with a Vanta INS, both of which have resulted in explant procedures. |
| Root cause | Device Design |
| Action | Medtronic issued an Urgent Medical Device Correction notice to impacted physicians on 06/06/2023 by letter. The notice explained the problem and the hazard associated with the use of the device during cardioversion procedures. It also provided the following information: Required Actions: " Please communicate to your patients the above Instruction for Prescribers (IFP) and Patient Therapy Guide (PTG) updates regarding programming considerations for cardioversion procedures with patients implanted with Vanta INS devices. " If a patient will be undergoing a cardioversion procedure (e.g., no |
| Quantity | 3791 devices |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.