Devices › Dorsal root ganglion stimulator for pain relief
Device brand name · Drg ipg
Proclaim DRG Implantable Pulse Generator: medical device reports filed with FDA
1,931 reports name it, 2018–2026. Manufacturer given most often on reports: Abbott Medical. Product code PMP.
- 1,931
- device reports naming the brand
- 0% of all MAUDE reports · about 232 a year
- 307
- reports, 12 months to August 2026
- 302 in the 12 months before
- 4.7%
- classified as malfunction
- 1.2% across the product code
- 0.3%
- classified as death, as reported
- 6 reports · not verified by FDA
1,931 medical device reports received by FDA name the brand "Proclaim DRG Implantable Pulse Generator" (drg ipg); the manufacturer given most often on reports is Abbott Medical; received from March 2018 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
307 reports arrived in the 12 months to August 2026, close to the 302 of 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 (95%), malfunction (4.7%) and death (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 wireless communication problem (12.7%), battery problem (8.5%) and insufficient device problem information (8.3%). The patient problems coded most often are implant pain, inadequate pain relief and failure of implant. 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
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
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 |
|---|---|---|---|
| Wireless communication problema wireless connection problem | 246 | 12.7% | 1.7% |
| Battery problema problem with the battery | 164 | 8.5% | 1.2% |
| Insufficient device problem information | 161 | 8.3% | 2.1% |
| Migrationthe device moved from where it was placed | 134 | 6.9% | 23.3% |
| Therapeutic or diagnostic output failure | 122 | 6.3% | 11.7% |
| Inappropriate/inadequate shock/stimulation | 30 | 1.6% | 0.8% |
| High impedance | 26 | 1.3% | 13.6% |
| Premature elective replacement indicator | 23 | 1.2% | 0.3% |
| Premature discharge of battery | 20 | 1% | 0.2% |
| Disconnection | 16 | 0.8% | 0.9% |
| Extracardiac stimulation | 16 | 0.8% | 0.1% |
| Temperature problem | 15 | 0.8% | 0.1% |
| Impedance problem | 9 | 0.5% | 2.2% |
| Unexpected shutdown | 8 | 0.4% | 0.1% |
| Separation failure | 7 | 0.4% | 0.2% |
| Failure to advance | 4 | 0.2% | 0.1% |
| Device damaged by another device | 3 | 0.2% | 0.1% |
| Improper or incorrect procedure or method | 3 | 0.2% | 0.2% |
| Application program freezes or fails to launch | 2 | 0.1% | 0.1% |
| Difficult to insertthe device was hard to insert | 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 |
|---|---|---|
| Implant pain | 646 | 33.5% |
| Inadequate pain relief | 585 | 30.3% |
| Failure of implant | 203 | 10.5% |
| Post operative wound infection | 114 | 5.9% |
| Painpain, site not specified | 75 | 3.9% |
| Discomfortdiscomfort | 52 | 2.7% |
| Undesired nerve stimulation | 43 | 2.2% |
| Wound dehiscencea wound reopened | 40 | 2.1% |
| Burning sensationa burning feeling | 33 | 1.7% |
| Fluid discharge | 22 | 1.1% |
| Hematomaa collection of blood under the skin or in tissue | 8 | 0.4% |
| Swelling/ edema | 8 | 0.4% |
| Hypersensitivity/allergic reaction | 6 | 0.3% |
| Twiddlers syndrome | 6 | 0.3% |
| Bacterial infectiona bacterial infection | 3 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Proclaim DRG Implantable Pulse Generator | Product code PMP | All MAUDE reports |
|---|---|---|---|
| Reports | 1,931 | 19,915 | 26,136,888 |
| Share of that pool | — | 9.7% | 0% |
| Classified as death, per 1,000 reports | 3 | 2 | 9 |
| Classified as injury | 95% | 98.6% | 36.2% |
| Classified as malfunction | 4.7% | 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% |
| 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% |
| 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 Proclaim DRG Implantable Pulse Generator reports
How many FDA reports name Proclaim DRG Implantable Pulse Generator?
1,931 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 307 in the latest 12 months.
What kinds of events are reported?
injury (95%), malfunction (4.7%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
wireless communication problem (12.7%), battery problem (8.5%), insufficient device problem information (8.3%), migration (6.9%) and therapeutic or diagnostic output failure (6.3%). 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 Proclaim DRG Implantable Pulse Generator 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.