Device manufacturer, as written on reports

Cyberonics - Houston: medical device reports filed with FDA

6,907 reports name it as the manufacturer of the device involved, 2015–2025.

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.

6,907
reports naming it as manufacturer: 0% of all MAUDE reports; 1
reports, 12 months to August 2026: 439 in the 12 months before; 49.2%
classified as malfunction: 62.3% across all reports; 6.3%
classified as death, as reported: 0.9% across all reports

6,907 medical device reports received by FDA give Cyberonics - Houston as the manufacturer of the device involved, 0% of the MAUDE database, from August 2015 to October 2025. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

1 reports arrived in the 12 months to August 2026, down 100% from 439 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 (49.2%), injury (44.5%) and death (6.3%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Pulse Gen Model 106	Stimulator, autonomic nerve, implanted for epilepsy	1,407	144	5.1%
Pulse Gen Model 1000	Stimulator, autonomic nerve, implanted for epilepsy	1,211	549	5.7%
Lead Model 304	Stimulator, autonomic nerve, implanted for epilepsy	922	272	0.1%
Lead Model 302	Stimulator, autonomic nerve, implanted for epilepsy	877	136	0%
Pulse Gen Model 103	Stimulator, autonomic nerve, implanted for epilepsy	573	34	8.5%
Pulse Gen Model 102	Stimulator, autonomic nerve, implanted for epilepsy	434	14	12.2%
Pulse Gen Model 105	Stimulator, autonomic nerve, implanted for epilepsy	263	7	6.7%
Programming Software	Stimulator, autonomic nerve, implanted for epilepsy	237	1	0%
Bipol Lead Model 300	Stimulator, autonomic nerve, implanted for epilepsy	200	12	0.1%
Pulse Gen Model 104	Stimulator, autonomic nerve, implanted for epilepsy	156	4	9%
Lead Model 303	Stimulator, autonomic nerve, implanted for epilepsy	136	28	0%
Lead Model Unknown	Stimulator, autonomic nerve, implanted for epilepsy	99	46	1.6%
Pulse Gen Model 102r	Stimulator, autonomic nerve, implanted for epilepsy	78	0	10.9%
Lead Model 300	Stimulator, autonomic nerve, implanted for epilepsy	67	22	0%
Pulse Gen Model 101	Stimulator, autonomic nerve, implanted for epilepsy	52	0	12.6%
Symmetry Gen Model 8103	Stimulator, autonomic nerve, implanted (depression)	48	23	3.8%
Pulse Gen Model Unk	Stimulator, autonomic nerve, implanted for epilepsy	19	7	13.6%
Lead Model Unk	Stimulator, autonomic nerve, implanted for epilepsy	9	0	0.3%
Pulse Gen Model unknown	Stimulator, autonomic nerve, implanted for epilepsy	4	40	10.9%
Ni	Set, administration, for peritoneal dialysis, disposable	2	1,587	1.8%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
LYJ	Stimulator, autonomic nerve, implanted for epilepsy	6,661	96.4%
MUZ	Stimulator, autonomic nerve, implanted (depression)	244	3.5%

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

Death6.3%438

Injury44.5%3,072

Malfunction49.2%3,397

Other0%0

Not given0%0

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Cyberonics - Houston reports

How many FDA device reports name Cyberonics - Houston as manufacturer?

6,907 reports through August 2026, 1 of them in the latest 12 months.

Which of its brands appear most often?

Pulse Gen Model 106 (1,407), Pulse Gen Model 1000 (1,211), Lead Model 304 (922), Lead Model 302 (877) and Pulse Gen Model 103 (573).

Which device types does it report on?

stimulator, autonomic nerve, implanted for epilepsy (96.4%) and stimulator, autonomic nerve, implanted (depression) (3.5%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.