Reported Reactions

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

Device brand name · Scs lead

Lamitrode TriCentrus 16 Lead, 60 cm: medical device reports filed with FDA

152 reports name it, 2024–2026. Manufacturer given most often on reports: St Jude Medical - Neuromodulation Puerto Rico. Product code LGW.

152
device reports naming the brand
0% of all MAUDE reports · about 68 a year
79
reports, 12 months to August 2026
61 in the 12 months before
0%
classified as malfunction
27.3% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 152 reports that name the brand "Lamitrode TriCentrus 16 Lead, 60 cm" (scs lead), received between April 2024 and August 2026; the manufacturer given most often on reports is St Jude Medical - Neuromodulation Puerto Rico. Spellings of one product vary from report to report.

79 reports arrived in the 12 months to August 2026, up 30% from 61 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 (100%); 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 migration (21.1%), high impedance (13.2%) and therapeutic or diagnostic output failure (13.2%). The patient problems coded most often are inadequate pain relief, post operative wound infection and hematoma. 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

0510Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 0Apr 2024: 1May 2024: 1Jun 2024: 3Jul 2024: 4Aug 2024: 3Sep 2024: 2Oct 2024: 2Nov 2024: 1Dec 2024: 72025Jan 2025: 4Feb 2025: 7Mar 2025: 4Apr 2025: 4May 2025: 10Jun 2025: 7Jul 2025: 9Aug 2025: 4Sep 2025: 6Oct 2025: 9Nov 2025: 5Dec 2025: 62026Jan 2026: 5Feb 2026: 3Mar 2026: 9Apr 2026: 4May 2026: 9Jun 2026: 8Jul 2026: 7Aug 2026: 8

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

038752024: 2420242025: 7520252026: 532026

Event type and report source

Event type, as classified on the report

Death0%0
Injury100%152
Malfunction0%0
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%152
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
Migrationthe device moved from where it was placed3221.1%5.7%
High impedance2013.2%9.7%
Therapeutic or diagnostic output failure2013.2%3.5%
Inappropriate/inadequate shock/stimulation53.3%3.7%
Fracturea broken bone21.3%1.8%
Impedance problem21.3%1.9%
Therapy delivered to incorrect body area10.7%1.5%

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
Inadequate pain relief7046.1%
Post operative wound infection1711.2%
Hematomaa collection of blood under the skin or in tissue138.6%
Numbnessnumbness138.6%
Muscle weakness/atrophy127.9%
Implant pain85.3%
Undesired nerve stimulation74.6%
Fluid discharge63.9%
Painpain, site not specified53.3%
Foreign body in patientpart of a device left in the patient42.6%
Abdominal painstomach or belly pain32%
Failure of implant32%
Cerebrospinal fluid leakage21.3%
Headachehead pain21.3%
Paralysis21.3%

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

In context

MeasureLamitrode TriCentrus 16 Lead, 60 cmProduct code LGWAll MAUDE reports
Reports152378,35526,136,888
Share of that pool—0%0%
Classified as death, per 1,000 reports059
Classified as injury100%72%36.2%
Classified as malfunction0%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 Lamitrode TriCentrus 16 Lead, 60 cm reports

How many FDA reports name Lamitrode TriCentrus 16 Lead, 60 cm?

152 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 79 in the latest 12 months.

What kinds of events are reported?

injury (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

migration (21.1%), high impedance (13.2%), therapeutic or diagnostic output failure (13.2%), inappropriate/inadequate shock/stimulation (3.3%) and fracture (1.3%). 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 Lamitrode TriCentrus 16 Lead, 60 cm 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.