Devices › Stimulator, peripheral nerve, implanted (pain relief)
Device brand name · Peripheral nerve stimulator
Freedom Peripheral Nerve Stimulator: medical device reports filed with FDA
987 reports name it, 2022–2026. Manufacturer given most often on reports: Curonix. Product code GZF.
- 987
- device reports naming the brand
- 0% of all MAUDE reports · about 242 a year
- 278
- reports, 12 months to August 2026
- 285 in the 12 months before
- 0.5%
- classified as malfunction
- 1.6% across the product code
- 1%
- classified as death, as reported
- 10 reports · not verified by FDA
987 medical device reports received by FDA name the brand "Freedom Peripheral Nerve Stimulator" (peripheral nerve stimulator); the manufacturer given most often on reports is Curonix; received from June 2022 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
278 reports arrived in the 12 months to August 2026, close to the 285 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 (98.5%), death (1%) and malfunction (0.5%); 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 (4.2%), off-label use (3.4%) and expulsion (2.9%). The patient problems coded most often are pain, erosion and skin infection. 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 | 41 | 4.2% | 6.9% |
| Off-label use | 34 | 3.4% | 0.9% |
| Expulsion | 29 | 2.9% | 0.7% |
| Migration or expulsion of device | 24 | 2.4% | 2.6% |
| Detachment of device or device componentpart of the device came off | 12 | 1.2% | 0.3% |
| Fracturea broken bone | 10 | 1% | 2% |
| Insufficient device problem information | 10 | 1% | 3.3% |
| Defective component | 8 | 0.8% | 0.2% |
| Improper or incorrect procedure or method | 6 | 0.6% | 0.9% |
| Manufacturing, packaging or shipping problem | 6 | 0.6% | 0.1% |
| Battery problema problem with the battery | 4 | 0.4% | 0.2% |
| Electrical /electronic property probleman electrical or electronic problem | 4 | 0.4% | 0.1% |
| Circuit failure | 3 | 0.3% | 0.2% |
| Power problem | 2 | 0.2% | 0% |
| Solder joint fracture | 2 | 0.2% | 0% |
| Contamination | 1 | 0.1% | 0% |
| Defective devicethe device was defective | 1 | 0.1% | 0.1% |
| Failure to deliverthe device did not deliver the dose or item | 1 | 0.1% | 0% |
| Material erosion | 1 | 0.1% | 0.6% |
| Moisture damage | 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 |
|---|---|---|
| Painpain, site not specified | 185 | 18.7% |
| Erosion | 145 | 14.7% |
| Skin infection | 144 | 14.6% |
| Impaired healingslow healing | 139 | 14.1% |
| Post operative wound infection | 88 | 8.9% |
| Swelling/ edema | 77 | 7.8% |
| Burning sensationa burning feeling | 71 | 7.2% |
| Electric shockan electric shock | 40 | 4.1% |
| Shock from patient lead(s) | 34 | 3.4% |
| Skin inflammation/ irritation | 32 | 3.2% |
| Fluid discharge | 30 | 3% |
| Wound dehiscencea wound reopened | 28 | 2.8% |
| Blistera blister | 19 | 1.9% |
| Discomfortdiscomfort | 17 | 1.7% |
| Hemorrhage/blood loss/bleeding | 17 | 1.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Freedom Peripheral Nerve Stimulator | Product code GZF | All MAUDE reports |
|---|---|---|---|
| Reports | 987 | 4,507 | 26,136,888 |
| Share of that pool | — | 21.9% | 0% |
| Classified as death, per 1,000 reports | 10 | 4 | 9 |
| Classified as injury | 98.5% | 97.9% | 36.2% |
| Classified as malfunction | 0.5% | 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 |
|---|---|---|---|
| Nalu Neurostimulation System | 1,361 | 184 | 0.1% |
| 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 Freedom Peripheral Nerve Stimulator reports
How many FDA reports name Freedom Peripheral Nerve Stimulator?
987 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 278 in the latest 12 months.
What kinds of events are reported?
injury (98.5%), death (1%) and malfunction (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
migration (4.2%), off-label use (3.4%), expulsion (2.9%), migration or expulsion of device (2.4%) and detachment of device or device component (1.2%). 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 Freedom Peripheral Nerve Stimulator 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.