Devices › Dorsal root ganglion stimulator for pain relief
Device brand name · Drg ins
Implantable Neurostimulator Kit: medical device reports filed with FDA
426 reports name it, 2016–2020. Manufacturer given most often on reports: St Jude Medical - Neuromodulation. Product code PMP.
- 426
- device reports naming the brand
- 0% of all MAUDE reports · about 42 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 1.4%
- classified as malfunction
- 1.2% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 426 reports that name the brand "Implantable Neurostimulator Kit" (drg ins), received between June 2016 and September 2020; 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 (98.6%) and malfunction (1.4%); 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 no device output (8%), wireless communication problem (4.2%) and communication or transmission problem (3.5%). The patient problems coded most often are inadequate pain relief, pain and discomfort. 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 Implantable Neurostimulator Kit was received in the five years to August 2026; the latest was received in September 2020.
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 |
|---|---|---|---|
| No device output | 34 | 8% | 0.2% |
| Wireless communication problema wireless connection problem | 18 | 4.2% | 1.7% |
| Communication or transmission problemthe device could not communicate or transmit | 15 | 3.5% | 0.1% |
| Therapeutic or diagnostic output failure | 11 | 2.6% | 11.7% |
| High impedance | 10 | 2.3% | 13.6% |
| Disconnection | 9 | 2.1% | 0.9% |
| Insufficient device problem information | 9 | 2.1% | 2.1% |
| Device inoperablethe device could not be used | 6 | 1.4% | 0.1% |
| Low impedance | 5 | 1.2% | 0.9% |
| Fracturea broken bone | 4 | 0.9% | 9.7% |
| Impedance problem | 4 | 0.9% | 2.2% |
| Premature discharge of battery | 4 | 0.9% | 0.2% |
| Unexpected shutdown | 4 | 0.9% | 0.1% |
| Premature end-of-life indicator | 3 | 0.7% | 0% |
| Device stops intermittentlythe device stopped now and then | 2 | 0.5% | 0% |
| Failure to deliver energy | 2 | 0.5% | 0.4% |
| Premature elective replacement indicator | 2 | 0.5% | 0.3% |
| Application program freezes or fails to launch | 1 | 0.2% | 0.1% |
| Charging problem | 1 | 0.2% | 0% |
| Device contamination with body fluid | 1 | 0.2% | 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 |
|---|---|---|
| Inadequate pain relief | 160 | 37.6% |
| Painpain, site not specified | 83 | 19.5% |
| Discomfortdiscomfort | 68 | 16% |
| Post operative wound infection | 32 | 7.5% |
| Device overstimulation of tissue | 12 | 2.8% |
| Weight changes | 11 | 2.6% |
| Falla fall | 8 | 1.9% |
| Wound dehiscencea wound reopened | 6 | 1.4% |
| Impaired healingslow healing | 5 | 1.2% |
| Hypersensitivity/allergic reaction | 3 | 0.7% |
| Cellulitisa skin infection | 2 | 0.5% |
| Erosion | 2 | 0.5% |
| Purulent discharge | 2 | 0.5% |
| Seromaa collection of fluid under the skin | 2 | 0.5% |
| Staphylococcus aureus | 2 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Implantable Neurostimulator Kit | Product code PMP | All MAUDE reports |
|---|---|---|---|
| Reports | 426 | 19,915 | 26,136,888 |
| Share of that pool | — | 2.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 98.6% | 98.6% | 36.2% |
| Classified as malfunction | 1.4% | 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% |
| 50cm Trial Lead Kit Slim Tip | 329 | 0 | 0.6% |
| 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 Implantable Neurostimulator Kit reports
How many FDA reports name Implantable Neurostimulator Kit?
426 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 (98.6%) and malfunction (1.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
no device output (8%), wireless communication problem (4.2%), communication or transmission problem (3.5%), therapeutic or diagnostic output failure (2.6%) 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 Implantable Neurostimulator Kit 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.