Stimulator, spinal-cord, totally implanted for pain relief: medical device reports filed with FDA

378,355 reports carry this product code, 1992–2026; 30 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

378,355
reports with this product code: 1.5% of all MAUDE reports; 31,154
reports, 12 months to August 2026: 31,416 in the 12 months before; 27.3%
classified as malfunction: 62.3% across all reports; 0.5%
classified as death, as reported: 0.9% across all reports

Product code LGW is FDA's classification for "Stimulator, spinal-cord, totally implanted for pain relief" (unknown panel), a class 3 device. 378,355 medical device reports carry this product code, 1.5% of the MAUDE database, from September 1992 to August 2026.

31,154 reports arrived in the 12 months to August 2026, close to the 31,416 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 (72%), malfunction (27.3%) and death (0.5%). 30 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Intellis	42,024	4,743	0%	71.8%
Octrode Lead Kit, 60cm Length	37,681	5,133	0.1%	0.8%
SureScan	32,332	490	0%	61.7%
Precision?	25,905	446	0.4%	15.7%
Proclaim 5 Elite Implantable Pulse Generator	20,813	2,057	0.1%	6.5%
Precision Spectra ?	16,857	971	0.5%	5.8%
Restore Ultra	13,496	39	0.1%	55.7%
Eon Mini IPG, 16-Channel Rechargeable	11,879	111	0.2%	3.5%
Restore Sensor	10,919	40	0.1%	59%
Spectra WaveWriter?	7,766	1,093	0.4%	0.2%
Penta 3mm Lead, 60 cm	6,968	839	0.3%	1.1%
Senza	6,423	718	15.1%	3.3%
Eon Mini	5,973	0	0.6%	8.5%
Proclaim 7 Elite Implantable Pulse Generator	5,836	333	0.1%	12.6%
WaveWriter Alpha?	4,965	1,591	0.9%	1.1%
Proclaim 5 Elite	4,819	0	0.2%	37%
Precision? Montage? MRI	4,767	786	0.3%	0.9%
Primeadvanced	4,567	16	0%	48.1%
Linear? ST	4,095	702	0.1%	5.3%
Synergy	3,968	84	3.5%	63.3%
Octrode	3,764	0	0.1%	5.2%
Proclaim 7 Elite	3,576	0	0.5%	30.6%
Restore Advanced	3,542	18	0.1%	52.7%
Restore	3,272	27	0.1%	49.4%
Implantable Neurostimulator	3,227	692	0.3%	63.6%
Prodigy MRI IPG, 16CH, Rechargeable	2,838	396	0%	0.4%
Octrode Lead Kit, 90cm Length	2,756	329	0.2%	0.4%
Protege IPG, 16-Channel Rechargeable	2,740	69	0.3%	0.4%
Inceptiv	2,729	1,687	0%	67.6%
WaveWriter Alpha? 16	2,570	879	0.8%	2%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Boston Scientific Neuromodulation	78,568	20.8%
Medtronic Puerto Rico Operations	78,336	20.7%
St Jude Medical - Neuromodulation Puerto Rico	59,725	15.8%
St Jude Medical - Neuromodulation	56,111	14.8%
Medtronic Med Rel Medtronic Puerto Rico	33,763	8.9%
Abbott Medical	26,317	7%
Medtronic Neuromodulation	13,746	3.6%
Nevro	6,606	1.7%
Mdt Puerto Rico Operations Juncos	4,460	1.2%
Advanced Neuromodulation Systems	2,989	0.8%
Mdt Puerto Rico Operations	1,842	0.5%
Saluda Medical	1,613	0.4%
Mdt Sofamor Danek Puerto Rico Mfg	1,314	0.3%
St Jude Medical Neuromodulation	1,209	0.3%
St Jude Medical - Neuromodulation Division	1,129	0.3%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0.5%1,930

Injury72%272,497

Malfunction27.3%103,300

Other0.1%566

Not given0%62

Who filed

Manufacturer report99.5%376,278

Voluntary report0.3%1,319

User facility report0%0

Distributor report0.1%566

Not given0.1%192

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Charging problem	42,504	11.2%
High impedance	36,660	9.7%
Battery problema problem with the battery	29,360	7.8%
Device operates differently than expectedthe device behaved unexpectedly	28,407	7.5%
Insufficient device problem information	25,875	6.8%
Migrationthe device moved from where it was placed	21,536	5.7%
Communication or transmission problemthe device could not communicate or transmit	18,877	5%
Migration or expulsion of device	17,740	4.7%
Failure to deliver energy	16,623	4.4%
Unexpected therapeutic results	16,260	4.3%
Inappropriate/inadequate shock/stimulation	13,946	3.7%
Therapeutic or diagnostic output failure	13,249	3.5%
Overheating of device	13,078	3.5%
Wireless communication problema wireless connection problem	12,825	3.4%
Improper or incorrect procedure or method	9,864	2.6%
Failure to interrogate	8,494	2.2%
Energy output problem	7,373	1.9%
Impedance problem	7,324	1.9%
Unintended collision	7,031	1.9%
Fracturea broken bone	6,875	1.8%

Questions about stimulator, spinal-cord, totally implanted for pain relief reports

What is product code LGW?

FDA's classification code for "Stimulator, spinal-cord, totally implanted for pain relief", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

378,355 reports through August 2026, 31,154 of them in the latest 12 months.

Which brands appear most often?

Intellis (42,024), Octrode Lead Kit, 60cm Length (37,681), SureScan (32,332), Precision? (25,905) and Proclaim 5 Elite Implantable Pulse Generator (20,813). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.