Recall Z-1574-2022 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Medtronic Neuromodulation
Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
| Date | Aug 25, 2022 (initiated Jul 26, 2022) |
| Status | Open, Classified |
| Reason | Potential communication issue in which the Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 may be unable to connect with a Vanta Implantable Neurostimulator (INS) Model 977006 when a patient is implanted with more than one neurostimulator. |
| Root cause | Under Investigation by firm |
| Action | On about 07/26/2022, Medtronic notified consignees via letter titled "URGENT: MEDICAL DEVICE CORRECTION" sent through courier service. The notification instructed consignees to hold off implanting more than one Vanta INS in a patient until software update is available and while not recommended, if implanting a patient with two (2) Vanta INSs, ensure the INSs are implanted on opposite sides of the body as noted in the Information for Prescribers labeling, and ensure each is configured with the CP App before implanting in a patient. Consignees were asked to complete and return the customer con |
| Quantity | 4386 downloaded software applications |
| Distribution | Worldwide distribution - US distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and Puerto Rico. The countries of Aus |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.