Devices › Stimulator, spinal-cord, totally implanted for pain relief
Device brand name · Stimulator spinal-cord totally implanted for pain relief
Linear? 3-4: medical device reports filed with FDA
589 reports name it, 2018–2026. Manufacturer given most often on reports: Boston Scientific Neuromodulation. Product code LGW.
- 589
- device reports naming the brand
- 0% of all MAUDE reports · about 73 a year
- 89
- reports, 12 months to August 2026
- 87 in the 12 months before
- 7.1%
- classified as malfunction
- 27.3% across the product code
- 0.2%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 589 reports that name the brand "Linear? 3-4" (stimulator spinal-cord totally implanted for pain relief), received between June 2018 and August 2026; the manufacturer given most often on reports is Boston Scientific Neuromodulation. Spellings of one product vary from report to report.
89 reports arrived in the 12 months to August 2026, close to the 87 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (92.7%), malfunction (7.1%) and death (0.2%); across all stimulator, spinal-cord, totally implanted for pain relief reports (product code LGW) death is recorded in 0.5% and malfunction in 27.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are unexpected therapeutic results (45.5%), migration (42.4%) and high impedance (21.4%). The patient problems coded most often are pain, inadequate pain relief and undesired nerve stimulation. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 378,355 reports carrying product code LGW. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Unexpected therapeutic results | 268 | 45.5% | 4.3% |
| Migrationthe device moved from where it was placed | 250 | 42.4% | 5.7% |
| High impedance | 126 | 21.4% | 9.7% |
| Fracturea broken bone | 44 | 7.5% | 1.8% |
| Inappropriate/inadequate shock/stimulation | 10 | 1.7% | 3.7% |
| Device dislodged or dislocated | 9 | 1.5% | 0.2% |
| Off-label use | 6 | 1% | 0% |
| Positioning problem | 6 | 1% | 1.5% |
| Defective devicethe device was defective | 5 | 0.8% | 0.6% |
| Difficult to removethe device was hard to remove | 4 | 0.7% | 0.1% |
| Difficult to insertthe device was hard to insert | 3 | 0.5% | 0.1% |
| Failure to disconnect | 3 | 0.5% | 0% |
| Nonstandard device | 3 | 0.5% | 0.2% |
| Intermittent energy output | 2 | 0.3% | 0.1% |
| Material twisted/bent | 2 | 0.3% | 0.1% |
| Structural problem | 2 | 0.3% | 0% |
| Battery problema problem with the battery | 1 | 0.2% | 7.8% |
| Charging problem | 1 | 0.2% | 11.2% |
| Human-device interface problem | 1 | 0.2% | 0.1% |
| Inadequate user interface | 1 | 0.2% | 0% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Painpain, site not specified | 154 | 26.1% |
| Inadequate pain relief | 82 | 13.9% |
| Undesired nerve stimulation | 53 | 9% |
| Discomfortdiscomfort | 24 | 4.1% |
| Bacterial infectiona bacterial infection | 22 | 3.7% |
| Erosion | 22 | 3.7% |
| Swelling/ edema | 14 | 2.4% |
| Falla fall | 11 | 1.9% |
| Cerebrospinal fluid leakage | 9 | 1.5% |
| Implant pain | 9 | 1.5% |
| Fever | 6 | 1% |
| Fluid discharge | 6 | 1% |
| Headachehead pain | 6 | 1% |
| Impaired healingslow healing | 6 | 1% |
| Cramp(s) /muscle spasm(s) | 5 | 0.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Linear? 3-4 | Product code LGW | All MAUDE reports |
|---|---|---|---|
| Reports | 589 | 378,355 | 26,136,888 |
| Share of that pool | — | 0.2% | 0% |
| Classified as death, per 1,000 reports | 2 | 5 | 9 |
| Classified as injury | 92.7% | 72% | 36.2% |
| Classified as malfunction | 7.1% | 27.3% | 62.3% |
| Filed by the manufacturer | 100% | 99.5% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code LGW
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Intellis | 42,032 | 4,743 | 0% |
| Octrode Lead Kit, 60cm Length | 47,037 | 5,133 | 0.1% |
| SureScan | 33,123 | 490 | 0% |
| Precision? | 26,020 | 446 | 0.4% |
| Proclaim 5 Elite Implantable Pulse Generator | 20,816 | 2,057 | 0.1% |
| Precision Spectra ? | 16,858 | 971 | 0.5% |
| Restore Ultra | 13,500 | 39 | 0.1% |
| Eon Mini IPG, 16-Channel Rechargeable | 14,176 | 111 | 0.2% |
| Restore Sensor | 10,934 | 40 | 0.1% |
| Spectra WaveWriter? | 7,766 | 1,093 | 0.4% |
| Penta 3mm Lead, 60 cm | 9,617 | 839 | 0.3% |
| Senza | 6,423 | 718 | 15.1% |
| Eon Mini | 9,122 | 0 | 0.6% |
| Proclaim 7 Elite Implantable Pulse Generator | 5,836 | 333 | 0.1% |
| WaveWriter Alpha? | 4,965 | 1,591 | 0.9% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Linear? 3-4 reports
How many FDA reports name Linear? 3-4?
589 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 89 in the latest 12 months.
What kinds of events are reported?
injury (92.7%), malfunction (7.1%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
unexpected therapeutic results (45.5%), migration (42.4%), high impedance (21.4%), fracture (7.5%) and inappropriate/inadequate shock/stimulation (1.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Linear? 3-4 was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.