—#197403

Product

Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E

FDA product code: LGW — Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Device class: Class 3
Medical specialty: Unknown
Affected lot / code info: GTIN 00763000447090: Serial/Lot Numbers: NPL3022869, NPL3022873, NPL3022049, NPL3022050, NPL3022795, NPL3022817, NPL3022190, NPL3022191, NPL3022052, NPL3022187, NPL3022193, NPL3022194, NPL3022195, NPL3022212, NPL3022213, NPL3022289, NPL3021964, NPL3022043, NPL3022044, NPL3022034, NPL3021984, NPL3021990

Why it was recalled

Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

The firm issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 12/03/2022 by mail. The notices explained the problems and the associated risks and provided the following: "Recommended Mitigation If the INS cannot be interrogated with Vanta PP App, contact Medtronic Technical Services at 1-800-707-0933. If needed, Medtronic will schedule an in-field service appointment with the managing SCS physician and the patient to diagnose and reset the INS." "Medtronic is working on a Vanta CP App software update that will resolve this issue and will communicate additional information when it becomes available."

Recalling firm

Firm: Medtronic Neuromodulation
Address: 7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2022-12-03
Posted by FDA: 2023-01-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197403. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.