Devices › Stimulator, autonomic nerve, implanted for epilepsy
Device brand name · Lead
Lead Model 304: medical device reports filed with FDA
3,329 reports name it, 2010–2026. Manufacturer given most often on reports: Livanova USA. Product code LYJ.
- 3,329
- device reports naming the brand
- 0% of all MAUDE reports · about 203 a year
- 272
- reports, 12 months to August 2026
- 299 in the 12 months before
- 74.2%
- classified as malfunction
- 58.7% across the product code
- 0.1%
- classified as death, as reported
- 4 reports · not verified by FDA
FDA's MAUDE database holds 3,329 reports that name the brand "Lead Model 304" (lead), received between February 2010 and August 2026; the manufacturer given most often on reports is Livanova USA. Spellings of one product vary from report to report.
272 reports arrived in the 12 months to August 2026, close to the 299 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 (74.2%), injury (25.7%) and death (0.1%); across all stimulator, autonomic nerve, implanted for epilepsy reports (product code LYJ) death is recorded in 5.6% and malfunction in 58.7%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are fracture (38.8%), high impedance (27.8%) and low impedance (6.2%). The patient problems coded most often are paralysis, seizures and appropriate clinical signs, symptoms and conditions term/code not available. 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."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 52,004 reports carrying product code LYJ. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Fracturea broken bone | 1,291 | 38.8% | 8.4% |
| High impedance | 924 | 27.8% | 18.1% |
| Low impedance | 206 | 6.2% | 1.4% |
| Device contamination with body fluid | 172 | 5.2% | 0.8% |
| Naturally worn | 163 | 4.9% | 0.7% |
| Insufficient device problem information | 147 | 4.4% | 9% |
| Corrodedthe device corroded | 124 | 3.7% | 0.8% |
| Electrical shorting | 71 | 2.1% | 0.4% |
| Mechanical problema mechanical problem | 67 | 2% | 0.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 50 | 1.5% | 4.5% |
| Breakthe device broke | 39 | 1.2% | 1.9% |
| Material twisted/bent | 39 | 1.2% | 0.2% |
| Extrusion | 24 | 0.7% | 0.3% |
| Fluid/blood leak | 23 | 0.7% | 0.3% |
| Therapy delivered to incorrect body area | 22 | 0.7% | 0.1% |
| Improper or incorrect procedure or method | 19 | 0.6% | 0.8% |
| Detachment of device or device componentpart of the device came off | 18 | 0.5% | 0.2% |
| Material protrusion/extrusion | 18 | 0.5% | 0.2% |
| Detachment of device component | 14 | 0.4% | 0.3% |
| Disconnection | 14 | 0.4% | 0.6% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Paralysis | 259 | 7.8% |
| Seizures | 183 | 5.5% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 127 | 3.8% |
| Painpain, site not specified | 123 | 3.7% |
| Convulsion, clonic | 117 | 3.5% |
| Neck painneck pain | 102 | 3.1% |
| Discomfortdiscomfort | 65 | 2% |
| Implant pain | 53 | 1.6% |
| Dysphagia/ odynophagia | 46 | 1.4% |
| Therapeutic response, decreased | 40 | 1.2% |
| Chest painchest pain | 37 | 1.1% |
| Pocket erosion | 37 | 1.1% |
| Post operative wound infection | 37 | 1.1% |
| Dyspneashortness of breath | 36 | 1.1% |
| Shock from patient lead(s) | 34 | 1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Lead Model 304 | Product code LYJ | All MAUDE reports |
|---|---|---|---|
| Reports | 3,329 | 52,004 | 26,136,888 |
| Share of that pool | — | 6.4% | 0% |
| Classified as death, per 1,000 reports | 1 | 56 | 9 |
| Classified as injury | 25.7% | 35.5% | 36.2% |
| Classified as malfunction | 74.2% | 58.7% | 62.3% |
| Filed by the manufacturer | 100% | 99.5% | 94.9% |
Shares are of reports, not 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."
Other brands with product code LYJ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Programming Software | 7,453 | 1 | 0% |
| Lead Model 302 | 7,259 | 136 | 0% |
| Pulse Gen Model 102 | 5,903 | 14 | 12.2% |
| Pulse Gen Model 103 | 4,518 | 34 | 8.5% |
| Pulse Gen Model 106 | 4,023 | 144 | 5.1% |
| Pulse Gen Model 1000 | 3,601 | 549 | 5.7% |
| Bipol Lead Model 300 | 1,955 | 12 | 0.1% |
| Pulse Gen Model Unk | 1,914 | 7 | 13.6% |
| Ncp Pulse Generator | 1,272 | 0 | 30% |
| Lead Model Unknown | 1,253 | 46 | 1.6% |
| Pulse Gen Model 101 | 1,210 | 0 | 12.6% |
| Pulse Gen Model 105 | 1,191 | 7 | 6.7% |
| Vns Therapy Pulse | 1,064 | 0 | 10.7% |
| Pulse Gen Model 102r | 985 | 0 | 10.9% |
| Pulse Gen Model 104 | 864 | 4 | 9% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Lead Model 304 reports
How many FDA reports name Lead Model 304?
3,329 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 272 in the latest 12 months.
What kinds of events are reported?
malfunction (74.2%), injury (25.7%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fracture (38.8%), high impedance (27.8%), low impedance (6.2%), device contamination with body fluid (5.2%) and naturally worn (4.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Lead Model 304 was at fault?
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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.