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Devices › Stimulator, spinal-cord, totally implanted for pain relief

Device brand name · Stimulator spinal-cord totally implanted for pain relief

Mattrix: medical device reports filed with FDA

188 reports name it, 1997–2020. Manufacturer given most often on reports: Medtronic Neuromodulation. Product code LGW.

188
device reports naming the brand
0% of all MAUDE reports · about 6 a year
0
reports, 12 months to August 2026
0 in the 12 months before
43.1%
classified as malfunction
27.3% across the product code
1.1%
classified as death, as reported
2 reports · not verified by FDA

188 medical device reports received by FDA name the brand "Mattrix" (stimulator spinal-cord totally implanted for pain relief); the manufacturer given most often on reports is Medtronic Neuromodulation; received from March 1997 to August 2020. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

0 reports arrived in the 12 months to August 2026, and none 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 (48.4%), malfunction (43.1%) and other (7.4%); 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 device operates differently than expected (28.7%), failure to deliver energy (8%) and intermittent continuity (8%). The patient problems coded most often are therapeutic effects, unexpected, pain and therapeutic response, decreased. 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

No report naming Mattrix was received in the five years to August 2026; the latest was received in August 2020.

By year received

012231997: 319971998: 62001: 820012002: 42005: 420052006: 32007: 320072008: 72009: 1920092010: 172011: 1020112012: 152013: 1220132014: 232015: 2220152016: 142017: 520172018: 52019: 520192020: 3

Event type and report source

Event type, as classified on the report

Death1.1%2
Injury48.4%91
Malfunction43.1%81
Other7.4%14
Not given0%0

Who filed the report

Manufacturer report100%188
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

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)ReportsShareShare across product code
Device operates differently than expectedthe device behaved unexpectedly5428.7%7.5%
Failure to deliver energy158%4.4%
Intermittent continuity158%1.5%
Inappropriate/inadequate shock/stimulation115.9%3.7%
Migration or expulsion of device115.9%4.7%
Communication or transmission problemthe device could not communicate or transmit73.7%5%
Failure to interrogate73.7%2.2%
Replace63.2%0.4%
Breakthe device broke52.7%1.4%
Device or device fragments location unknown42.1%0.2%
Electromagnetic compatibility problem31.6%0.8%
Insufficient device problem information31.6%6.8%
Unintended collision31.6%1.9%
Battery problema problem with the battery21.1%7.8%
Degraded21.1%0%
Device displays incorrect message21.1%1.8%
Device inoperablethe device could not be used21.1%0.7%
Device operational issue21.1%0%
Device stops intermittentlythe device stopped now and then21.1%0.2%
Low battery21.1%1.2%

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)ReportsShare
Therapeutic effects, unexpected2814.9%
Painpain, site not specified2211.7%
Therapeutic response, decreased179%
Inadequate pain relief168.5%
Electric shockan electric shock126.4%
Complaint, ill-defined115.9%
Surgical procedure, additional52.7%
Undesired nerve stimulation52.7%
Discomfortdiscomfort42.1%
Identified diagnosis42.1%
Burning sensationa burning feeling31.6%
Ambulation or postural difficulties21.1%
Falla fall21.1%
Numbnessnumbness21.1%
Seizures21.1%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureMattrixProduct code LGWAll MAUDE reports
Reports188378,35526,136,888
Share of that pool—0%0%
Classified as death, per 1,000 reports1159
Classified as injury48.4%72%36.2%
Classified as malfunction43.1%27.3%62.3%
Filed by the manufacturer100%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

BrandReportsLatest 12 monthsClassified as death
Intellis42,0324,7430%
Octrode Lead Kit, 60cm Length47,0375,1330.1%
SureScan33,1234900%
Precision?26,0204460.4%
Proclaim 5 Elite Implantable Pulse Generator20,8162,0570.1%
Precision Spectra ?16,8589710.5%
Restore Ultra13,500390.1%
Eon Mini IPG, 16-Channel Rechargeable14,1761110.2%
Restore Sensor10,934400.1%
Spectra WaveWriter?7,7661,0930.4%
Penta 3mm Lead, 60 cm9,6178390.3%
Senza6,42371815.1%
Eon Mini9,12200.6%
Proclaim 7 Elite Implantable Pulse Generator5,8363330.1%
WaveWriter Alpha?4,9651,5910.9%

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 Mattrix reports

How many FDA reports name Mattrix?

188 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

injury (48.4%), malfunction (43.1%) and other (7.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device operates differently than expected (28.7%), failure to deliver energy (8%), intermittent continuity (8%), inappropriate/inadequate shock/stimulation (5.9%) and migration or expulsion of device (5.9%). 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 Mattrix 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.