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FDA product code GZF · class 2 · Neurology
Stimulator, peripheral nerve, implanted (pain relief): medical device reports filed with FDA
4,507 reports carry this product code, 1999–2026; 30 brands with a page.
- 4,507
- reports with this product code
- 0% of all MAUDE reports
- 460
- reports, 12 months to August 2026
- 673 in the 12 months before
- 1.6%
- classified as malfunction
- 62.3% across all reports
- 0.4%
- classified as death, as reported
- 0.9% across all reports
Product code GZF is FDA's classification for "Stimulator, peripheral nerve, implanted (pain relief)" (neurology panel), a class 2 device. 4,507 medical device reports carry this product code, 0% of the MAUDE database, from January 1999 to August 2026.
460 reports arrived in the 12 months to August 2026, down 32% from 673 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 (97.9%), malfunction (1.6%) and death (0.4%). 30 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| St Jude Medical - Neuromodulation | 1,676 | 37.2% |
| Nalu Medical | 1,157 | 25.7% |
| Medtronic Neuromodulation | 89 | 2% |
| St Jude Medical Neuromodulation | 42 | 0.9% |
| Advanced Neuromodulation Systems | 3 | 0.1% |
| Abbott Medical | 1 | 0% |
| Ipg Mfg Switzerland | 1 | 0% |
| Mdt Puerto Rico Operations Med Rel | 1 | 0% |
| Medtronic Puerto Rico Operations | 1 | 0% |
| St Jude Medical - Neuromodulation Puerto Rico | 1 | 0% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Migrationthe device moved from where it was placed | 310 | 6.9% |
| Device operates differently than expectedthe device behaved unexpectedly | 291 | 6.5% |
| Impedance problem | 158 | 3.5% |
| Insufficient device problem information | 150 | 3.3% |
| High impedance | 139 | 3.1% |
| Intermittent communication failure | 117 | 2.6% |
| Migration or expulsion of device | 115 | 2.6% |
| Fracturea broken bone | 90 | 2% |
| Device unsafe to use in environment | 48 | 1.1% |
| Off-label use | 41 | 0.9% |
| Improper or incorrect procedure or method | 39 | 0.9% |
| Malposition of device | 38 | 0.8% |
| Expulsion | 32 | 0.7% |
| Lack of effect | 27 | 0.6% |
| Material erosion | 25 | 0.6% |
| Inappropriate/inadequate shock/stimulation | 24 | 0.5% |
| Therapy delivered to incorrect body area | 17 | 0.4% |
| Material protrusion/extrusion | 15 | 0.3% |
| Breakthe device broke | 14 | 0.3% |
| Low impedance | 14 | 0.3% |
Questions about stimulator, peripheral nerve, implanted (pain relief) reports
What is product code GZF?
FDA's classification code for "Stimulator, peripheral nerve, implanted (pain relief)", class 2, reviewed by the neurology panel. Every device report carries the product code of the device involved.
How many reports carry this code?
4,507 reports through August 2026, 460 of them in the latest 12 months.
Which brands appear most often?
Nalu Neurostimulation System (1,151), Freedom Peripheral Nerve Stimulator (987), Quattrode Lead Wide Spaced, 60 cm (599), Quattrode Lead Wide Spaced, 90 cm (574) and Stimq Neurostimulator (314). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.