Generator, lesion, radiofrequency: medical device reports filed with FDA

1,825 reports carry this product code, 1992–2026; 5 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

1,825
reports with this product code: 0% of all MAUDE reports; 68
reports, 12 months to August 2026: 94 in the 12 months before; 53.8%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

Product code GXD is FDA's classification for "Generator, lesion, radiofrequency" (neurology panel), a class 2 device. 1,825 medical device reports carry this product code, 0% of the MAUDE database, from July 1992 to August 2026.

68 reports arrived in the 12 months to August 2026, down 28% from 94 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 malfunction (53.8%), injury (41.9%) and other (3.4%). 5 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

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
4 Lesion NT2000 Pain Management RF Generator	395	3	0%	42.3%
3 Lesion Nt1100 Pain Management Rf Generator	170	0	0%	27.6%
Ampere RF Ablation Generator	3	14	1.1%	55.9%
Stockert 70 Rf Generator	2	0	4.2%	33.5%
Constellation With Laser	1	0	0.1%	78.4%

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	405	22.2%
Stryker Instruments Kalamazoo	138	7.6%
Stryker Instruments-Kalamazoo	67	3.7%
Stryker Instruments-A Division Of Stryker	45	2.5%
Boston Scientific Neuromodulation	22	1.2%
Covidien Valleylab	14	0.8%
Avanos Medical	10	0.5%
Medtronic Neuromodulation	6	0.3%
Stryker Osteosynthesis Freiburg	6	0.3%
Baylis Medical	3	0.2%
Stryker Endoscopy Puerto Rico	3	0.2%
Stryker Instruments	3	0.2%
Valleylab	3	0.2%
Biosense Webster	1	0.1%
Horizon Medical Products	1	0.1%

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

Death0.3%5

Injury41.9%764

Malfunction53.8%982

Other3.4%62

Not given0.7%12

Who filed

Manufacturer report94.6%1,726

Voluntary report3.6%65

User facility report0%0

Distributor report0%0

Not given1.9%34

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Temperature problem	138	7.6%
Device operates differently than expectedthe device behaved unexpectedly	137	7.5%
Insufficient heating	136	7.5%
Device displays incorrect message	106	5.8%
Output problem	86	4.7%
Fracturea broken bone	77	4.2%
Insufficient device problem information	72	3.9%
Communication or transmission problemthe device could not communicate or transmit	68	3.7%
Self-activation or keying	66	3.6%
Failure to power up	53	2.9%
Smoking	41	2.2%
Thermal decomposition of device	40	2.2%
High impedance	34	1.9%
Unexpected shutdown	33	1.8%
Impedance problem	29	1.6%
Connection problema connection problem	27	1.5%
Device inoperablethe device could not be used	27	1.5%
Overheating of device	25	1.4%
Material deformation	24	1.3%
Failure to deliver energy	23	1.3%

Questions about generator, lesion, radiofrequency reports

What is product code GXD?

FDA's classification code for "Generator, lesion, radiofrequency", class 2, reviewed by the neurology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

1,825 reports through August 2026, 68 of them in the latest 12 months.

Which brands appear most often?

4 Lesion NT2000 Pain Management RF Generator (395), 3 Lesion Nt1100 Pain Management Rf Generator (170), Ampere RF Ablation Generator (3), Stockert 70 Rf Generator (2) and Constellation With Laser (1). 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.