Devices › Stimulator, autonomic nerve, implanted for epilepsy
Device brand name · Lead
Lead Model 303: medical device reports filed with FDA
559 reports name it, 2008–2026. Manufacturer given most often on reports: Livanova USA. Product code LYJ.
- 559
- device reports naming the brand
- 0% of all MAUDE reports · about 31 a year
- 28
- reports, 12 months to August 2026
- 30 in the 12 months before
- 66.5%
- classified as malfunction
- 58.7% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
559 medical device reports received by FDA name the brand "Lead Model 303" (lead); the manufacturer given most often on reports is Livanova USA; received from July 2008 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
28 reports arrived in the 12 months to August 2026, close to the 30 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 (66.5%) and injury (33.5%); 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 (27.4%), high impedance (23.3%) and low impedance (10.2%). The patient problems coded most often are paralysis, seizures and pain. 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 | 153 | 27.4% | 8.4% |
| High impedance | 130 | 23.3% | 18.1% |
| Low impedance | 57 | 10.2% | 1.4% |
| Insufficient device problem information | 33 | 5.9% | 9% |
| Electrical shorting | 28 | 5% | 0.4% |
| Device contamination with body fluid | 19 | 3.4% | 0.8% |
| Corrodedthe device corroded | 16 | 2.9% | 0.8% |
| Naturally worn | 16 | 2.9% | 0.7% |
| Mechanical problema mechanical problem | 15 | 2.7% | 0.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 11 | 2% | 4.5% |
| Detachment of device or device componentpart of the device came off | 9 | 1.6% | 0.2% |
| Difficult to insertthe device was hard to insert | 8 | 1.4% | 0.1% |
| Device inoperablethe device could not be used | 6 | 1.1% | 1.5% |
| Breakthe device broke | 5 | 0.9% | 1.9% |
| Detachment of device component | 4 | 0.7% | 0.3% |
| Therapy delivered to incorrect body area | 4 | 0.7% | 0.1% |
| Extrusion | 3 | 0.5% | 0.3% |
| Material twisted/bent | 3 | 0.5% | 0.2% |
| Scratched material | 3 | 0.5% | 0.1% |
| Battery problema problem with the battery | 2 | 0.4% | 3.4% |
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 | 50 | 8.9% |
| Seizures | 38 | 6.8% |
| Painpain, site not specified | 29 | 5.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 25 | 4.5% |
| Convulsion, clonic | 20 | 3.6% |
| Neck painneck pain | 20 | 3.6% |
| Therapeutic response, decreased | 14 | 2.5% |
| Dyspneashortness of breath | 11 | 2% |
| Discomfortdiscomfort | 10 | 1.8% |
| Implant pain | 9 | 1.6% |
| Muscle spasm(s) | 9 | 1.6% |
| Paresis | 8 | 1.4% |
| Swellingswelling | 8 | 1.4% |
| Dysphasia | 7 | 1.3% |
| Edemaswelling from fluid | 7 | 1.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Lead Model 303 | Product code LYJ | All MAUDE reports |
|---|---|---|---|
| Reports | 559 | 52,004 | 26,136,888 |
| Share of that pool | — | 1.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 56 | 9 |
| Classified as injury | 33.5% | 35.5% | 36.2% |
| Classified as malfunction | 66.5% | 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% |
| Lead Model 304 | 3,329 | 272 | 0.1% |
| 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% |
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 303 reports
How many FDA reports name Lead Model 303?
559 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 28 in the latest 12 months.
What kinds of events are reported?
malfunction (66.5%) and injury (33.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fracture (27.4%), high impedance (23.3%), low impedance (10.2%), insufficient device problem information (5.9%) and electrical shorting (5%). 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 303 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.