Devices › Implanted brain stimulator for epilepsy
Device brand name · Neuropace rns system
NeuroPace RNS System: medical device reports filed with FDA
736 reports name it, 2014–2026. Manufacturer given most often on reports: Neuropace. Product code PFN.
- 736
- device reports naming the brand
- 0% of all MAUDE reports · about 62 a year
- 121
- reports, 12 months to August 2026
- 64 in the 12 months before
- 20%
- classified as malfunction
- 19.8% across the product code
- 0.3%
- classified as death, as reported
- 2 reports · not verified by FDA
FDA's MAUDE database holds 736 reports that name the brand "NeuroPace RNS System" (neuropace rns system), received between September 2014 and August 2026; the manufacturer given most often on reports is Neuropace. Spellings of one product vary from report to report.
121 reports arrived in the 12 months to August 2026, up 89% from 64 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 (79.6%), malfunction (20%) and death (0.3%); across all implanted brain stimulator for epilepsy reports (product code PFN) death is recorded in 0.3% and malfunction in 19.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are signal artifact/noise (13.6%), high impedance (9.2%) and impedance problem (6.1%). The patient problems coded most often are bacterial infection, wound dehiscence and erosion. 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 754 reports carrying product code PFN. 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 |
|---|---|---|---|
| Signal artifact/noise | 100 | 13.6% | 13.3% |
| High impedance | 68 | 9.2% | 9% |
| Impedance problem | 45 | 6.1% | 6.1% |
| Failure to interrogate | 37 | 5% | 4.9% |
| Breakthe device broke | 33 | 4.5% | 4.4% |
| Communication or transmission problemthe device could not communicate or transmit | 28 | 3.8% | 3.8% |
| Insufficient device problem information | 14 | 1.9% | 2.5% |
| Premature discharge of battery | 11 | 1.5% | 1.5% |
| Failure to transmit record | 8 | 1.1% | 1.1% |
| Device remains activated | 5 | 0.7% | 0.7% |
| Fracturea broken bone | 5 | 0.7% | 0.7% |
| Battery problema problem with the battery | 4 | 0.5% | 0.5% |
| Positioning problem | 4 | 0.5% | 0.5% |
| Migrationthe device moved from where it was placed | 3 | 0.4% | 0.4% |
| Deformation due to compressive stress | 2 | 0.3% | 0.3% |
| Detachment of device or device componentpart of the device came off | 2 | 0.3% | 0.3% |
| Device slipped | 2 | 0.3% | 0.3% |
| Low impedance | 2 | 0.3% | 0.3% |
| Mechanical problema mechanical problem | 2 | 0.3% | 0.3% |
| Dent in material | 1 | 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 |
|---|---|---|
| Bacterial infectiona bacterial infection | 180 | 24.5% |
| Wound dehiscencea wound reopened | 64 | 8.7% |
| Erosion | 55 | 7.5% |
| Fluid discharge | 44 | 6% |
| Impaired healingslow healing | 35 | 4.8% |
| Purulent discharge | 31 | 4.2% |
| Intracranial hemorrhage | 29 | 3.9% |
| Drug resistant bacterial infection | 27 | 3.7% |
| Hematomaa collection of blood under the skin or in tissue | 24 | 3.3% |
| Painpain, site not specified | 21 | 2.9% |
| Headachehead pain | 20 | 2.7% |
| Hemorrhage/blood loss/bleeding | 20 | 2.7% |
| Swelling/ edema | 18 | 2.4% |
| Discharge | 10 | 1.4% |
| Skin erosion | 8 | 1.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | NeuroPace RNS System | Product code PFN | All MAUDE reports |
|---|---|---|---|
| Reports | 736 | 754 | 26,136,888 |
| Share of that pool | — | 97.6% | 0% |
| Classified as death, per 1,000 reports | 3 | 3 | 9 |
| Classified as injury | 79.6% | 79.7% | 36.2% |
| Classified as malfunction | 20% | 19.8% | 62.3% |
| Filed by the manufacturer | 99.9% | 98.1% | 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."
Questions about NeuroPace RNS System reports
How many FDA reports name NeuroPace RNS System?
736 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 121 in the latest 12 months.
What kinds of events are reported?
injury (79.6%), malfunction (20%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
signal artifact/noise (13.6%), high impedance (9.2%), impedance problem (6.1%), failure to interrogate (5%) and break (4.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that NeuroPace RNS System 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.