Home › Device types › LGW
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
FDA product code LGW · Class 3 · Unknown
1,216
Registered devices
375,696
Adverse events
96
Recalls
0
510(k) clearances
Devices with this code
Nevro® — NEVRO CORP.Evoke® 12C Percutaneous Lead Kit - 90 cm — SALUDA MEDICAL PTY LIMITEDNA — MEDTRONIC, INC.NA — MEDTRONIC, INC.PISCES-QUAD PLUS ™ — MEDTRONIC, INC.Precision™ — BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPrecision®, NA — BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPrecision ™ — BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONSJM™ — ST. JUDE MEDICAL, INC.N/A — MEDTRONIC, INC.RESUME® TL — MEDTRONIC, INC.NA — MEDTRONIC, INC.NA — Thoratec CorporationNevro® — NEVRO CORP.Algovita® — Greatbatch LtdSJM™ — ST. JUDE MEDICAL, INC.Injex® — MEDTRONIC, INC.NA — BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONEvoke® CAP12 Percutaneous Lead Kit - 60 cm — SALUDA MEDICAL PTY LIMITEDNA — BOSTON SCIENTIFIC NEUROMODULATION CORPORATIONPISCES-QUAD PLUS ™ — MEDTRONIC, INC.Lamitrode Tripole™ — ST. JUDE MEDICAL, INC.SJM™ — ADVANCED NEUROMODULATION SYSTEMS, INC.Exclaim™ — ST. JUDE MEDICAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-17 | Boston Scientific Neuromodulation Corporation | Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which ma |
| 2026-04-29 | Boston Scientific Neuromodulation Corporation | Sterile anchors my lack sterility assurance. |
| 2025-12-03 | Medtronic Neuromodulation | Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure. |
| 2025-11-20 | Medtronic Neuromodulation | Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and t |
| 2025-10-06 | Abbott Medical | There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation |
| 2025-03-04 | Medtronic Neuromodulation | There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequen |
| 2024-09-18 | Medtronic Neuromodulation | The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use. |
| 2024-08-21 | Medtronic Neuromodulation | Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical |
| 2024-07-17 | Boston Scientific Neuromodulation Corporation | Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may |
| 2024-05-16 | Abbott Medical | The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in |
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