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Lamitrode Tripole™
ST. JUDE MEDICAL, INC. · Model 3214 · UDI-DI 05415067017789
LGW
Prescription
0
510(k) clearances
0
Adverse events
96
Recalls
55
Facilities
Description
16C Lead, 60 cm
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 may lead to inadequate |
| 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 the patient experienc |
| 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 (DBS) Implantable P |
| 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 sequence is used. |
| 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 replacements. |
| 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 lead to transient l |
| 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 product labeling. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.