Devices › Stimulator, autonomic nerve, implanted for epilepsy
Device brand name · Lead
Lead Model Unknown: medical device reports filed with FDA
1,253 reports name it, 2007–2026. Manufacturer given most often on reports: Cyberonics. Product code LYJ.
- 1,253
- device reports naming the brand
- 0% of all MAUDE reports · about 65 a year
- 46
- reports, 12 months to August 2026
- 41 in the 12 months before
- 83.4%
- classified as malfunction
- 58.7% across the product code
- 1.6%
- classified as death, as reported
- 20 reports · not verified by FDA
1,253 medical device reports received by FDA name the brand "Lead Model Unknown" (lead); the manufacturer given most often on reports is Cyberonics; received from April 2007 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
46 reports arrived in the 12 months to August 2026, up 12% from 41 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 (83.4%), injury (15%) and death (1.6%); 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 high impedance (57.2%), fracture (18.4%) and insufficient device problem information (5.3%). The patient problems coded most often are seizures, paralysis and therapeutic response, decreased. 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 |
|---|---|---|---|
| High impedance | 717 | 57.2% | 18.1% |
| Fracturea broken bone | 231 | 18.4% | 8.4% |
| Insufficient device problem information | 67 | 5.3% | 9% |
| Breakthe device broke | 59 | 4.7% | 1.9% |
| Device operates differently than expectedthe device behaved unexpectedly | 45 | 3.6% | 4.5% |
| Low impedance | 39 | 3.1% | 1.4% |
| Device dislodged or dislocated | 25 | 2% | 0.2% |
| Device inoperablethe device could not be used | 15 | 1.2% | 1.5% |
| Battery problema problem with the battery | 14 | 1.1% | 3.4% |
| Electrical shorting | 14 | 1.1% | 0.4% |
| Explanted | 13 | 1% | 4.6% |
| Detachment of device component | 11 | 0.9% | 0.3% |
| Lead(s), fracture of | 10 | 0.8% | 0.3% |
| Corrodedthe device corroded | 8 | 0.6% | 0.8% |
| Device displays incorrect message | 8 | 0.6% | 2.1% |
| Device remains implanted | 8 | 0.6% | 4.9% |
| Extrusion | 8 | 0.6% | 0.3% |
| Mechanical problema mechanical problem | 8 | 0.6% | 0.7% |
| Naturally worn | 8 | 0.6% | 0.7% |
| Migration or expulsion of device | 7 | 0.6% | 1.1% |
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 |
|---|---|---|
| Seizures | 112 | 8.9% |
| Paralysis | 73 | 5.8% |
| Therapeutic response, decreased | 46 | 3.7% |
| Deaththe patient died; cause not stated by this term | 36 | 2.9% |
| Painpain, site not specified | 34 | 2.7% |
| Neck painneck pain | 28 | 2.2% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 17 | 1.4% |
| Paresis | 17 | 1.4% |
| Chest painchest pain | 15 | 1.2% |
| Convulsion, clonic | 14 | 1.1% |
| Scar tissue | 13 | 1% |
| Discomfortdiscomfort | 12 | 1% |
| Therapy/non-surgical treatment, additional | 12 | 1% |
| Dysphasia | 11 | 0.9% |
| Head injurya head injury | 11 | 0.9% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Lead Model Unknown | Product code LYJ | All MAUDE reports |
|---|---|---|---|
| Reports | 1,253 | 52,004 | 26,136,888 |
| Share of that pool | — | 2.4% | 0% |
| Classified as death, per 1,000 reports | 16 | 56 | 9 |
| Classified as injury | 15% | 35.5% | 36.2% |
| Classified as malfunction | 83.4% | 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% |
| 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 Unknown reports
How many FDA reports name Lead Model Unknown?
1,253 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 46 in the latest 12 months.
What kinds of events are reported?
malfunction (83.4%), injury (15%) and death (1.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
high impedance (57.2%), fracture (18.4%), insufficient device problem information (5.3%), break (4.7%) and device operates differently than expected (3.6%). 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 Unknown 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.