PRODUCT CODE LGW
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
2026-06-03 – 2026-08-31 · FDA release 2026-09-29
Death reports · review source evidence. This is a lead for evidence review. A report does not establish causation, fault, an eligible claimant or a future lawsuit. Multiple devices may appear in a report; device counts cannot be added into a unique-patient total.
Reports · 90 days
7,918Prior 90 days: 8,065Injury reports
6,399Source-classified event typeDeath reports
78Reported relationship is unverifiedReporting change
-1.8%Descriptive change, not a risk estimateMalfunction-classified reports in this window: 1,410. These are separate from injury/death classifications.
Recent source reports
Up to five example reports. Statistics above cover all matching API-index entries in the stated windows; these examples are not a representative sample.
Received 2026-08-31 · Injury
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: High impedance
Proclaim¿ 5 Elite Implantable Pulse Generator
Read FDA report 50515039 ↗Received 2026-08-31 · Injury
Patient problems: Post Operative Wound Infection
Device problems: Adverse Event Without Identified Device or Use Problem
INTELLIS
Read FDA report 50515558 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Failure to Interrogate; Overheating of Device; Communication or Transmission Problem
Orion RC SCS IPG
Read FDA report 50517793 ↗Received 2026-08-31 · Injury
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: Wireless Communication Problem
Inceptiv
Read FDA report 50517833 ↗Received 2026-08-31 · Malfunction
Patient problems: No Clinical Signs, Symptoms or Conditions
Device problems: High impedance
Investigate before assessing a potential case
Review the complete report, model and device identifiers, recalls, medical literature, alternative causes and current court records. Check follow-ups and duplicate submissions. Report volume alone cannot establish incidence, liability or case value.