Devices › Dorsal root ganglion stimulator for pain relief
Device brand name · Drg lead
50cm Trial Lead Kit Slim Tip: medical device reports filed with FDA
329 reports name it, 2016–2019. Manufacturer given most often on reports: St Jude Medical - Neuromodulation. Product code PMP.
- 329
- device reports naming the brand
- 0% of all MAUDE reports · about 32 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 0.3%
- classified as malfunction
- 1.2% across the product code
- 0.6%
- classified as death, as reported
- 2 reports · not verified by FDA
FDA's MAUDE database holds 329 reports that name the brand "50cm Trial Lead Kit Slim Tip" (drg lead), received between May 2016 and November 2019; 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 (99.1%), death (0.6%) and malfunction (0.3%); across all dorsal root ganglion stimulator for pain relief reports (product code PMP) death is recorded in 0.2% and malfunction in 1.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (1.8%), improper or incorrect procedure or method (1.5%) and fracture (1.2%). The patient problems coded most often are cerebrospinal fluid leakage, pain and headache. 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 50cm Trial Lead Kit Slim Tip was received in the five years to August 2026; the latest was received in November 2019.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 19,915 reports carrying product code PMP. 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 |
|---|---|---|---|
| Breakthe device broke | 6 | 1.8% | 0.4% |
| Improper or incorrect procedure or method | 5 | 1.5% | 0.2% |
| Fracturea broken bone | 4 | 1.2% | 9.7% |
| Impedance problem | 3 | 0.9% | 2.2% |
| Therapeutic or diagnostic output failure | 2 | 0.6% | 11.7% |
| Device damaged by another device | 1 | 0.3% | 0.1% |
| Fluid/blood leak | 1 | 0.3% | 0% |
| Material fragmentation | 1 | 0.3% | 1.9% |
| Material separation | 1 | 0.3% | 0.1% |
| Off-label use | 1 | 0.3% | 0% |
| Positioning problem | 1 | 0.3% | 0% |
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 |
|---|---|---|
| Cerebrospinal fluid leakage | 94 | 28.6% |
| Painpain, site not specified | 46 | 14% |
| Headachehead pain | 40 | 12.2% |
| Headache, lumbar puncture | 37 | 11.2% |
| Inadequate pain relief | 27 | 8.2% |
| Numbnessnumbness | 27 | 8.2% |
| Weakness | 19 | 5.8% |
| Post operative wound infection | 13 | 4% |
| Fever | 10 | 3% |
| Discomfortdiscomfort | 6 | 1.8% |
| Hematomaa collection of blood under the skin or in tissue | 5 | 1.5% |
| Low oxygen saturation | 5 | 1.5% |
| Thrombosis | 5 | 1.5% |
| Muscle weakness/atrophy | 4 | 1.2% |
| Myocardial infarctionheart attack | 4 | 1.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | 50cm Trial Lead Kit Slim Tip | Product code PMP | All MAUDE reports |
|---|---|---|---|
| Reports | 329 | 19,915 | 26,136,888 |
| Share of that pool | — | 1.7% | 0% |
| Classified as death, per 1,000 reports | 6 | 2 | 9 |
| Classified as injury | 99.1% | 98.6% | 36.2% |
| Classified as malfunction | 0.3% | 1.2% | 62.3% |
| Filed by the manufacturer | 100% | 99.7% | 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 PMP
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Kit Implantable Slim Tip Lead, 50cm | 9,959 | 1,417 | 0.1% |
| 50cm Implant Lead Kit Slim Tip | 2,715 | 0 | 0.1% |
| Proclaim DRG Implantable Pulse Generator | 1,931 | 307 | 0.3% |
| Kit Implantable Slim Tip Lead, 90cm | 1,425 | 119 | 0.3% |
| 90cm Implant Lead Kit Slim Tip | 706 | 0 | 0.7% |
| Implantable Neurostimulator Kit | 426 | 0 | 0% |
| Kit Trial Slim Tip Lead 50cm | 251 | 17 | 2% |
| Proclaim Drg Ipg | 178 | 0 | 0.6% |
| Axium | 267 | 14 | 13.1% |
| Implantable Neurostimulator | 6,395 | 692 | 0.3% |
| Infinity 7 Implantable Pulse Generator | 1,258 | 147 | 0.5% |
| SCS Lead | 163 | 29 | 0% |
| Lead | 1,234 | 118 | 0.5% |
| Proclaim 5 Elite Implantable Pulse Generator | 20,816 | 2,057 | 0.1% |
| Cardiomems Patient Electronic System | 4,593 | 738 | 0% |
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 50cm Trial Lead Kit Slim Tip reports
How many FDA reports name 50cm Trial Lead Kit Slim Tip?
329 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 (99.1%), death (0.6%) and malfunction (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (1.8%), improper or incorrect procedure or method (1.5%), fracture (1.2%), impedance problem (0.9%) and therapeutic or diagnostic output failure (0.6%). 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 50cm Trial Lead Kit Slim Tip 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.