Device manufacturer, as written on reports

Livanova USA: medical device reports filed with FDA

10,393 reports name it as the manufacturer of the device involved, 2007–2026.

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.

10,393
reports naming it as manufacturer: 0% of all MAUDE reports; 698
reports, 12 months to August 2026: 869 in the 12 months before; 57.6%
classified as malfunction: 62.3% across all reports; 3.5%
classified as death, as reported: 0.9% across all reports

10,393 medical device reports received by FDA give Livanova USA as the manufacturer of the device involved, 0% of the MAUDE database, from April 2007 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

698 reports arrived in the 12 months to August 2026, down 20% from 869 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 (57.6%), injury (38.8%) and death (3.5%). 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 1000	Stimulator, autonomic nerve, implanted for epilepsy	2,038	549	5.7%
Pulse Gen Model 106	Stimulator, autonomic nerve, implanted for epilepsy	1,800	144	5.1%
Lead Model 304	Stimulator, autonomic nerve, implanted for epilepsy	1,430	272	0.1%
Lead Model 302	Stimulator, autonomic nerve, implanted for epilepsy	1,329	136	0%
Pulse Gen Model 103	Stimulator, autonomic nerve, implanted for epilepsy	627	34	8.5%
Lead Model Unknown	Stimulator, autonomic nerve, implanted for epilepsy	394	46	1.6%
Pulse Gen Model 102	Stimulator, autonomic nerve, implanted for epilepsy	338	14	12.2%
Pulse Gen Model Unk	Stimulator, autonomic nerve, implanted for epilepsy	318	7	13.6%
Pulse Gen Model 105	Stimulator, autonomic nerve, implanted for epilepsy	285	7	6.7%
Pulse Gen Model 104	Stimulator, autonomic nerve, implanted for epilepsy	230	4	9%
Bipol Lead Model 300	Stimulator, autonomic nerve, implanted for epilepsy	225	12	0.1%
Lead Model 303	Stimulator, autonomic nerve, implanted for epilepsy	209	28	0%
Programming Software	Stimulator, autonomic nerve, implanted for epilepsy	180	1	0%
Symmetry Gen Model 8103	Stimulator, autonomic nerve, implanted (depression)	144	23	3.8%
Pulse Gen Model unknown	Stimulator, autonomic nerve, implanted for epilepsy	101	40	10.9%
Lead Model 300	Stimulator, autonomic nerve, implanted for epilepsy	87	22	0%
Pulse Gen Model 102r	Stimulator, autonomic nerve, implanted for epilepsy	65	0	10.9%
Lead Model Unk	Stimulator, autonomic nerve, implanted for epilepsy	29	0	0.3%
Pulse Gen Model 101	Stimulator, autonomic nerve, implanted for epilepsy	12	0	12.6%
Heater-Cooler System 3t	Controller, temperature, cardiopulmonary bypass	4	8	3.5%
Bipol Lead Model 302	Stimulator, autonomic nerve, implanted for epilepsy	2	0	0%

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	9,573	92.1%
MUZ	Stimulator, autonomic nerve, implanted (depression)	527	5.1%
DWE	Tubing, pump, cardiopulmonary bypass	131	1.3%
DWF	Catheter, cannula and tubing, vascular, cardiopulmonary bypass	77	0.7%
DWC	Controller, temperature, cardiopulmonary bypass	18	0.2%
GEI	Electrosurgical, cutting & coagulation & accessories	17	0.2%
DRE	Dilator, vessel, for percutaneous catheterization	5	0%
DTL	Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass	5	0%
DTQ	Console, heart-lung machine, cardiopulmonary bypass	4	0%
DTZ	Oxygenator, cardiopulmonary bypass	4	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

Death3.5%366

Injury38.8%4,036

Malfunction57.6%5,988

Other0%1

Not given0%2

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

Questions about Livanova USA reports

How many FDA device reports name Livanova USA as manufacturer?

10,393 reports through August 2026, 698 of them in the latest 12 months.

Which of its brands appear most often?

Pulse Gen Model 1000 (2,038), Pulse Gen Model 106 (1,800), Lead Model 304 (1,430), Lead Model 302 (1,329) and Pulse Gen Model 103 (627).

Which device types does it report on?

stimulator, autonomic nerve, implanted for epilepsy (92.1%), stimulator, autonomic nerve, implanted (depression) (5.1%), tubing, pump, cardiopulmonary bypass (1.3%) and catheter, cannula and tubing, vascular, cardiopulmonary bypass (0.7%).

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.