Devices › Stimulator, peripheral nerve, implanted (pain relief)
Device brand name · Peripheral nerve stimulator
Nalu Neurostimulation System: medical device reports filed with FDA
1,361 reports name it, 2020–2026. Manufacturer given most often on reports: Nalu Medical. Product code GZF.
- 1,361
- device reports naming the brand
- 0% of all MAUDE reports · about 224 a year
- 184
- reports, 12 months to August 2026
- 414 in the 12 months before
- 0.2%
- classified as malfunction
- 1.6% across the product code
- 0.1%
- classified as death, as reported
- 2 reports · not verified by FDA
1,361 medical device reports received by FDA name the brand "Nalu Neurostimulation System" (peripheral nerve stimulator); the manufacturer given most often on reports is Nalu Medical; received from June 2020 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
184 reports arrived in the 12 months to August 2026, down 56% from 414 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 (99.6%), malfunction (0.2%) and death (0.1%); across all stimulator, peripheral nerve, implanted (pain relief) reports (product code GZF) death is recorded in 0.4% and malfunction in 1.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are migration (19.8%), insufficient device problem information (10.9%) and intermittent communication failure (9.8%). The patient problems coded most often are inadequate pain relief, post operative wound infection 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
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 4,507 reports carrying product code GZF. 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 |
|---|---|---|---|
| Migrationthe device moved from where it was placed | 269 | 19.8% | 6.9% |
| Insufficient device problem information | 148 | 10.9% | 3.3% |
| Intermittent communication failure | 134 | 9.8% | 2.6% |
| Impedance problem | 53 | 3.9% | 3.5% |
| Device unsafe to use in environment | 51 | 3.7% | 1.1% |
| Malposition of device | 42 | 3.1% | 0.8% |
| Fracturea broken bone | 35 | 2.6% | 2% |
| Improper or incorrect procedure or method | 33 | 2.4% | 0.9% |
| Lack of effect | 25 | 1.8% | 0.6% |
| High impedance | 9 | 0.7% | 3.1% |
| Patient-device incompatibilitythe device did not suit the patient | 8 | 0.6% | 0.2% |
| Circuit failure | 6 | 0.4% | 0.2% |
| Device appears to trigger rejection | 5 | 0.4% | 0.1% |
| Device difficult to setup or prepare | 4 | 0.3% | 0% |
| Device-device incompatibility | 3 | 0.2% | 0.1% |
| Therapy delivered to incorrect body area | 3 | 0.2% | 0.4% |
| Communication or transmission problemthe device could not communicate or transmit | 2 | 0.1% | 0.1% |
| Migration or expulsion of device | 2 | 0.1% | 2.6% |
| Patient device interaction problem | 2 | 0.1% | 0.2% |
| Activation problem | 1 | 0.1% | 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 | 669 | 49.2% |
| Post operative wound infection | 157 | 11.5% |
| Discomfortdiscomfort | 54 | 4% |
| Wound dehiscencea wound reopened | 36 | 2.6% |
| Impaired healingslow healing | 31 | 2.3% |
| Skin erosion | 29 | 2.1% |
| Painpain, site not specified | 25 | 1.8% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 23 | 1.7% |
| Implant pain | 19 | 1.4% |
| Cellulitisa skin infection | 8 | 0.6% |
| Erosion | 4 | 0.3% |
| Cerebrospinal fluid leakage | 3 | 0.2% |
| Headachehead pain | 3 | 0.2% |
| Skin infection | 3 | 0.2% |
| Skin inflammation/ irritation | 3 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Nalu Neurostimulation System | Product code GZF | All MAUDE reports |
|---|---|---|---|
| Reports | 1,361 | 4,507 | 26,136,888 |
| Share of that pool | — | 30.2% | 0% |
| Classified as death, per 1,000 reports | 1 | 4 | 9 |
| Classified as injury | 99.6% | 97.9% | 36.2% |
| Classified as malfunction | 0.2% | 1.6% | 62.3% |
| Filed by the manufacturer | 99.9% | 99.1% | 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."
Other brands with product code GZF
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Freedom Peripheral Nerve Stimulator | 987 | 278 | 1% |
| Quattrode Lead Wide Spaced, 60 cm | 1,989 | 143 | 0.1% |
| Quattrode Lead Wide Spaced, 90 cm | 1,229 | 25 | 0% |
| Stimq Neurostimulator | 316 | 0 | 0.9% |
| Quattrode | 2,208 | 0 | 0% |
| Quattrode Lead Wide Spaced 30 Cm | 538 | 8 | 0% |
| Freedom Neurostimulator | 162 | 0 | 0.6% |
| Mattrix | 188 | 0 | 1.1% |
| Swift-Lock Anchor | 2,396 | 206 | 0% |
| Octrode Lead Kit, 60cm Length | 47,037 | 5,133 | 0.1% |
| Extension Dual 4 Channel 60cm | 247 | 2 | 0% |
| Cinch Lead Anchor | 313 | 24 | 0% |
| Quattrode Lead, 3/6mm, 60 cm | 255 | 9 | 0% |
| Eon Mini | 9,122 | 0 | 0.6% |
| Extension Dual 4 Channel 10cm | 343 | 4 | 0.3% |
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 Nalu Neurostimulation System reports
How many FDA reports name Nalu Neurostimulation System?
1,361 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 184 in the latest 12 months.
What kinds of events are reported?
injury (99.6%), malfunction (0.2%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
migration (19.8%), insufficient device problem information (10.9%), intermittent communication failure (9.8%), impedance problem (3.9%) and device unsafe to use in environment (3.7%). 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 Nalu Neurostimulation 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.