Devices › Stimulator, spinal-cord, totally implanted for pain relief
Device brand name · Scs lead
Penta: medical device reports filed with FDA
2,532 reports name it, 2012–2015. Manufacturer given most often on reports: St Jude Medical - Neuromodulation. Product code LGW.
- 2,532
- device reports naming the brand
- 0% of all MAUDE reports · about 181 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 6.2%
- classified as malfunction
- 27.3% across the product code
- 0.1%
- classified as death, as reported
- 3 reports · not verified by FDA
FDA's MAUDE database holds 2,532 reports that name the brand "Penta" (scs lead), received between July 2012 and December 2015; the manufacturer given most often on reports is St Jude Medical - Neuromodulation. Spellings of one product vary from report to report.
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 (93.6%), malfunction (6.2%) and death (0.1%); 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 (59.2%), migration or expulsion of device (9.6%) and impedance problem (7.5%). The patient problems coded most often are inadequate pain relief, pain and therapeutic effects, unexpected. 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 Penta was received in the five years to August 2026; the latest was received in December 2015.
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 |
|---|---|---|---|
| Device operates differently than expectedthe device behaved unexpectedly | 1,498 | 59.2% | 7.5% |
| Migration or expulsion of device | 244 | 9.6% | 4.7% |
| Impedance problem | 190 | 7.5% | 1.9% |
| Therapy delivered to incorrect body area | 189 | 7.5% | 1.5% |
| High impedance | 58 | 2.3% | 9.7% |
| Inappropriate/inadequate shock/stimulation | 44 | 1.7% | 3.7% |
| Insufficient device problem information | 40 | 1.6% | 6.8% |
| Fracturea broken bone | 38 | 1.5% | 1.8% |
| Temperature problem | 36 | 1.4% | 1.5% |
| Low impedance | 25 | 1% | 0.7% |
| Difficult to advance | 24 | 0.9% | 0.1% |
| Disconnection | 19 | 0.8% | 0.4% |
| Malposition of device | 13 | 0.5% | 1.3% |
| Device stops intermittentlythe device stopped now and then | 10 | 0.4% | 0.2% |
| Cardiac enzyme evaluation, erroneous | 6 | 0.2% | 0% |
| Failure to advance | 6 | 0.2% | 0% |
| Unintended movement | 5 | 0.2% | 0.2% |
| Kinkedthe tube or line kinked | 4 | 0.2% | 0.1% |
| Detachment of device component | 2 | 0.1% | 0.1% |
| Detachment of device or device componentpart of the device came off | 2 | 0.1% | 0.1% |
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 |
|---|---|---|
| Inadequate pain relief | 1,454 | 57.4% |
| Painpain, site not specified | 334 | 13.2% |
| Therapeutic effects, unexpected | 228 | 9% |
| Post operative wound infection | 187 | 7.4% |
| Discomfortdiscomfort | 166 | 6.6% |
| Falla fall | 132 | 5.2% |
| Device overstimulation of tissue | 106 | 4.2% |
| Neurological deficit/dysfunction | 96 | 3.8% |
| Burning sensationa burning feeling | 72 | 2.8% |
| Numbnessnumbness | 54 | 2.1% |
| Hematomaa collection of blood under the skin or in tissue | 40 | 1.6% |
| Shockshock, a collapse of the circulation | 28 | 1.1% |
| Swellingswelling | 28 | 1.1% |
| Headachehead pain | 27 | 1.1% |
| Weakness | 26 | 1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Penta | Product code LGW | All MAUDE reports |
|---|---|---|---|
| Reports | 2,532 | 378,355 | 26,136,888 |
| Share of that pool | — | 0.7% | 0% |
| Classified as death, per 1,000 reports | 1 | 5 | 9 |
| Classified as injury | 93.6% | 72% | 36.2% |
| Classified as malfunction | 6.2% | 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 Penta reports
How many FDA reports name Penta?
2,532 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 (93.6%), malfunction (6.2%) and death (0.1%). "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 (59.2%), migration or expulsion of device (9.6%), impedance problem (7.5%), therapy delivered to incorrect body area (7.5%) and high impedance (2.3%). 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 Penta 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.