Stimulator, autonomic nerve, implanted for epilepsy: medical device reports filed with FDA

52,004 reports carry this product code, 1998–2026; 29 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.

52,004
reports with this product code: 0.2% of all MAUDE reports; 1,461
reports, 12 months to August 2026: 1,470 in the 12 months before; 58.7%
classified as malfunction: 62.3% across all reports; 5.6%
classified as death, as reported: 0.9% across all reports

Product code LYJ is FDA's classification for "Stimulator, autonomic nerve, implanted for epilepsy" (unknown panel), a class 3 device. 52,004 medical device reports carry this product code, 0.2% of the MAUDE database, from January 1998 to August 2026.

1,461 reports arrived in the 12 months to August 2026, close to the 1,470 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 malfunction (58.7%), injury (35.5%) and death (5.6%). 29 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
Programming Software	7,088	1	0%	99.3%
Lead Model 302	6,900	136	0%	91.9%
Pulse Gen Model 102	5,188	14	12.2%	25.8%
Pulse Gen Model 103	4,422	34	8.5%	29.8%
Pulse Gen Model 106	3,985	144	5.1%	39.6%
Pulse Gen Model 1000	3,570	549	5.7%	38.9%
Lead Model 304	3,262	272	0.1%	74.2%
Bipol Lead Model 300	1,885	12	0.1%	92.7%
Pulse Gen Model Unk	1,839	7	13.6%	25.8%
Ncp Pulse Generator	1,272	0	30%	16.8%
Lead Model Unknown	1,233	46	1.6%	83.4%
Pulse Gen Model 101	1,196	0	12.6%	41.8%
Pulse Gen Model 105	1,159	7	6.7%	32.5%
Vns Therapy Pulse	1,045	0	10.7%	18.3%
Pulse Gen Model 102r	978	0	10.9%	26.6%
Pulse Gen Model 104	859	4	9%	35%
Ncp Bipolar Lead	729	0	0%	83.5%
Programming Wand	687	0	0%	99.7%
Lead Model 303	533	28	0%	66.5%
Cyberonics Neurocybernetic Prosthesis	429	0	26.6%	23.5%
Vns Therapy Lead	412	0	0%	50.2%
Lead Model 300	389	22	0%	93.9%
Pulse Gen Model unknown	327	40	10.9%	22.1%
Lead Model Unk	301	0	0.3%	80.6%
Ni	202	1,587	1.8%	29.5%
Bipol Lead Model 302	146	0	0%	81.5%
Symmetry Gen Model 8103	12	23	3.8%	22.5%
Eon 16-Channel Ipg	1	0	1.6%	41.6%
MED-EL Combi 40+ Cochlear Implant System	1	0	0%	56.6%

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
Cyberonics	34,645	66.6%
Livanova USA	9,573	18.4%
Cyberonics - Houston	6,661	12.8%
Houston	1,049	2%
Advanced Neuromodulation Systems	1	0%
Med-El Elektromedizinische Geraete	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

Death5.6%2,920

Injury35.5%18,442

Malfunction58.7%30,519

Other0.2%83

Not given0.1%40

Who filed

Manufacturer report99.5%51,743

Voluntary report0.4%186

User facility report0%0

Distributor report0%1

Not given0.1%74

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

Device problems coded

Device problem (FDA code)	Reports	Share
High impedance	9,426	18.1%
Insufficient device problem information	4,705	9%
Fracturea broken bone	4,362	8.4%
Device remains implanted	2,557	4.9%
Explanted	2,414	4.6%
Device operates differently than expectedthe device behaved unexpectedly	2,340	4.5%
Battery problema problem with the battery	1,794	3.4%
Replace	1,333	2.6%
Failure to interrogate	1,289	2.5%
Use of incorrect control/treatment settings	1,197	2.3%
Device displays incorrect message	1,088	2.1%
Breakthe device broke	1,014	1.9%
Communication or transmission problemthe device could not communicate or transmit	814	1.6%
Device inoperablethe device could not be used	773	1.5%
No display/image	763	1.5%
Low impedance	732	1.4%
Premature end-of-life indicator	686	1.3%
Programming issue	664	1.3%
Premature discharge of battery	661	1.3%
Migration or expulsion of device	560	1.1%

Questions about stimulator, autonomic nerve, implanted for epilepsy reports

What is product code LYJ?

FDA's classification code for "Stimulator, autonomic nerve, implanted for epilepsy", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

52,004 reports through August 2026, 1,461 of them in the latest 12 months.

Which brands appear most often?

Programming Software (7,088), Lead Model 302 (6,900), Pulse Gen Model 102 (5,188), Pulse Gen Model 103 (4,422) and Pulse Gen Model 106 (3,985). 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.