Devices › Stimulator, spinal-cord, totally implanted for pain relief
Device brand name · Stimulator spinal-cord totally implanted for pain relief
WaveWriter Alpha? Prime 16: medical device reports filed with FDA
1,100 reports name it, 2021–2026. Manufacturer given most often on reports: Boston Scientific Neuromodulation. Product code LGW.
- 1,100
- device reports naming the brand
- 0% of all MAUDE reports · about 213 a year
- 435
- reports, 12 months to August 2026
- 276 in the 12 months before
- 1.5%
- classified as malfunction
- 27.3% across the product code
- 1.5%
- classified as death, as reported
- 16 reports · not verified by FDA
1,100 medical device reports received by FDA name the brand "WaveWriter Alpha? Prime 16" (stimulator spinal-cord totally implanted for pain relief); the manufacturer given most often on reports is Boston Scientific Neuromodulation; received from May 2021 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
435 reports arrived in the 12 months to August 2026, up 58% from 276 in 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 (97.1%), death (1.5%) and malfunction (1.5%); 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 (29.6%), battery problem (26.4%) and migration (5.3%). The patient problems coded most often are pain, implant pain and discomfort. 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 | 326 | 29.6% | 4.3% |
| Battery problema problem with the battery | 290 | 26.4% | 7.8% |
| Migrationthe device moved from where it was placed | 58 | 5.3% | 5.7% |
| Inappropriate/inadequate shock/stimulation | 36 | 3.3% | 3.7% |
| Premature discharge of battery | 23 | 2.1% | 1.1% |
| High impedance | 20 | 1.8% | 9.7% |
| Defective devicethe device was defective | 18 | 1.6% | 0.6% |
| Wireless communication problema wireless connection problem | 16 | 1.5% | 3.4% |
| Charging problem | 10 | 0.9% | 11.2% |
| Nonstandard device | 9 | 0.8% | 0.2% |
| Fracturea broken bone | 5 | 0.5% | 1.8% |
| Intermittent energy output | 5 | 0.5% | 0.1% |
| Overheating of device | 5 | 0.5% | 3.5% |
| Device displays incorrect message | 3 | 0.3% | 1.8% |
| Impedance problem | 3 | 0.3% | 1.9% |
| Application program problem | 2 | 0.2% | 0.2% |
| Failure to disconnect | 2 | 0.2% | 0% |
| Off-label use | 2 | 0.2% | 0% |
| Positioning problem | 2 | 0.2% | 1.5% |
| Device dislodged or dislocated | 1 | 0.1% | 0.2% |
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 | 337 | 30.6% |
| Implant pain | 111 | 10.1% |
| Discomfortdiscomfort | 90 | 8.2% |
| Bacterial infectiona bacterial infection | 59 | 5.4% |
| Undesired nerve stimulation | 34 | 3.1% |
| Fluid discharge | 32 | 2.9% |
| Inadequate pain relief | 31 | 2.8% |
| Impaired healingslow healing | 24 | 2.2% |
| Swelling/ edema | 23 | 2.1% |
| Burning sensationa burning feeling | 22 | 2% |
| Wound dehiscencea wound reopened | 22 | 2% |
| Erosion | 20 | 1.8% |
| Inappropriate device stimulation of tissue | 15 | 1.4% |
| Erythemaskin redness | 13 | 1.2% |
| Falla fall | 13 | 1.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | WaveWriter Alpha? Prime 16 | Product code LGW | All MAUDE reports |
|---|---|---|---|
| Reports | 1,100 | 378,355 | 26,136,888 |
| Share of that pool | — | 0.3% | 0% |
| Classified as death, per 1,000 reports | 15 | 5 | 9 |
| Classified as injury | 97.1% | 72% | 36.2% |
| Classified as malfunction | 1.5% | 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 WaveWriter Alpha? Prime 16 reports
How many FDA reports name WaveWriter Alpha? Prime 16?
1,100 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 435 in the latest 12 months.
What kinds of events are reported?
injury (97.1%), death (1.5%) and malfunction (1.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
unexpected therapeutic results (29.6%), battery problem (26.4%), migration (5.3%), inappropriate/inadequate shock/stimulation (3.3%) and premature discharge of battery (2.1%). 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 WaveWriter Alpha? Prime 16 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.