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FDA product code GZB · class 2 · Neurology
Stimulator, spinal-cord, implanted (pain relief): medical device reports filed with FDA
43,947 reports carry this product code, 1993–2026; 30 brands with a page.
- 43,947
- reports with this product code
- 0.2% of all MAUDE reports
- 265
- reports, 12 months to August 2026
- 313 in the 12 months before
- 4.1%
- classified as malfunction
- 62.3% across all reports
- 0.4%
- classified as death, as reported
- 0.9% across all reports
Product code GZB is FDA's classification for "Stimulator, spinal-cord, implanted (pain relief)" (neurology panel), a class 2 device. 43,947 medical device reports carry this product code, 0.2% of the MAUDE database, from September 1993 to August 2026.
265 reports arrived in the 12 months to August 2026, down 15% from 313 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 (94.3%), malfunction (4.1%) and other (1%). 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 | 32,348 | 73.6% |
| St Jude Medical - Neuromodulation Puerto Rico | 3,818 | 8.7% |
| St Jude Medical Neuromodulation | 2,122 | 4.8% |
| Abbott Medical | 504 | 1.1% |
| Medtronic | 489 | 1.1% |
| Advanced Neuromodulation Systems | 231 | 0.5% |
| Nalu Medical | 217 | 0.5% |
| Medtronic Med Rel Medtronic Puerto Rico | 146 | 0.3% |
| Medtronic Neuromodulation | 123 | 0.3% |
| St Jude Medical - Neuromodulation Division | 104 | 0.2% |
| Advanced Bionics | 101 | 0.2% |
| Medtronic Puerto Rico Operations | 81 | 0.2% |
| Neuro - Villalba | 48 | 0.1% |
| St Jude Medical | 22 | 0.1% |
| Medtronic Europe Sarl | 11 | 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 |
|---|---|---|
| Device operates differently than expectedthe device behaved unexpectedly | 7,608 | 17.3% |
| High impedance | 3,282 | 7.5% |
| Impedance problem | 2,517 | 5.7% |
| Temperature problem | 1,960 | 4.5% |
| Communication or transmission problemthe device could not communicate or transmit | 1,682 | 3.8% |
| Migration or expulsion of device | 1,605 | 3.7% |
| No device output | 1,313 | 3% |
| Fracturea broken bone | 1,020 | 2.3% |
| Low impedance | 879 | 2% |
| Therapy delivered to incorrect body area | 836 | 1.9% |
| Charging problem | 783 | 1.8% |
| Explanted | 695 | 1.6% |
| Disconnection | 599 | 1.4% |
| Device inoperablethe device could not be used | 579 | 1.3% |
| Insufficient device problem information | 517 | 1.2% |
| Nonstandard device | 510 | 1.2% |
| Failure to charge | 414 | 0.9% |
| Unintended movement | 391 | 0.9% |
| Inappropriate/inadequate shock/stimulation | 349 | 0.8% |
| Breakthe device broke | 289 | 0.7% |
Questions about stimulator, spinal-cord, implanted (pain relief) reports
What is product code GZB?
FDA's classification code for "Stimulator, spinal-cord, 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?
43,947 reports through August 2026, 265 of them in the latest 12 months.
Which brands appear most often?
Octrode Lead Kit, 60cm Length (9,339), Octrode (4,638), Eon Mini (3,141), Penta 3mm Lead, 60 cm (2,647) and Eon Mini IPG, 16-Channel Rechargeable (2,294). 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.