Devices › Stimulator, autonomic nerve, implanted (depression)
Device brand name · Generator
Symmetry Gen Model 8103: medical device reports filed with FDA
209 reports name it, 2020–2026. Manufacturer given most often on reports: Livanova USA. Product code MUZ.
- 209
- device reports naming the brand
- 0% of all MAUDE reports · about 32 a year
- 23
- reports, 12 months to August 2026
- 43 in the 12 months before
- 22.5%
- classified as malfunction
- 48.9% across the product code
- 3.8%
- classified as death, as reported
- 8 reports · not verified by FDA
FDA's MAUDE database holds 209 reports that name the brand "Symmetry Gen Model 8103" (generator), received between January 2020 and August 2026; the manufacturer given most often on reports is Livanova USA. Spellings of one product vary from report to report.
23 reports arrived in the 12 months to August 2026, down 47% from 43 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 injury (73.7%), malfunction (22.5%) and death (3.8%); across all stimulator, autonomic nerve, implanted (depression) reports (product code MUZ) death is recorded in 3.3% and malfunction in 48.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are premature discharge of battery (3.3%), insufficient device problem information (2.4%) and erratic or intermittent display (1.4%). The patient problems coded most often are depression, appropriate clinical signs, symptoms and conditions term/code not available and suicidal ideation. 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 2,368 reports carrying product code MUZ. 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 |
|---|---|---|---|
| Premature discharge of battery | 7 | 3.3% | 0.8% |
| Insufficient device problem information | 5 | 2.4% | 11.1% |
| Erratic or intermittent display | 3 | 1.4% | 0.2% |
| High impedance | 3 | 1.4% | 12.4% |
| Electrostatic discharge | 2 | 1% | 0.2% |
| Incomplete or inadequate connection | 2 | 1% | 0.3% |
| Failure to interrogate | 1 | 0.5% | 2.9% |
| Premature elective replacement indicator | 1 | 0.5% | 0.1% |
| Therapeutic or diagnostic output failure | 1 | 0.5% | 0.2% |
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 |
|---|---|---|
| Depressionlow mood | 52 | 24.9% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 27 | 12.9% |
| Suicidal ideationthoughts of suicide | 20 | 9.6% |
| Post operative wound infection | 18 | 8.6% |
| Syncope/fainting | 14 | 6.7% |
| Implant pain | 9 | 4.3% |
| Dysphagia/ odynophagia | 8 | 3.8% |
| Dyspneashortness of breath | 6 | 2.9% |
| Bradycardiaslow heart rate | 5 | 2.4% |
| Hemorrhage/blood loss/bleeding | 5 | 2.4% |
| Ambulation or postural difficulties | 4 | 1.9% |
| Pneumonialung infection | 4 | 1.9% |
| Anxietyanxiety | 3 | 1.4% |
| Breathing-related sleep disorder | 3 | 1.4% |
| Headachehead pain | 3 | 1.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Symmetry Gen Model 8103 | Product code MUZ | All MAUDE reports |
|---|---|---|---|
| Reports | 209 | 2,368 | 26,136,888 |
| Share of that pool | — | 8.8% | 0% |
| Classified as death, per 1,000 reports | 38 | 33 | 9 |
| Classified as injury | 73.7% | 47.2% | 36.2% |
| Classified as malfunction | 22.5% | 48.9% | 62.3% |
| Filed by the manufacturer | 100% | 99.1% | 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 MUZ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Pulse Gen Model 102 | 5,903 | 14 | 12.2% |
| Lead Model 302 | 7,259 | 136 | 0% |
| Programming Software | 7,453 | 1 | 0% |
| Pulse Gen Model 103 | 4,518 | 34 | 8.5% |
| Pulse Gen Model Unk | 1,914 | 7 | 13.6% |
| Bipol Lead Model 300 | 1,955 | 12 | 0.1% |
| Lead Model 304 | 3,329 | 272 | 0.1% |
| Programming Wand | 738 | 0 | 0% |
| Pulse Gen Model 106 | 4,023 | 144 | 5.1% |
| Pulse Gen Model 105 | 1,191 | 7 | 6.7% |
| Pulse Gen Model 1000 | 3,601 | 549 | 5.7% |
| Lead Model 303 | 559 | 28 | 0% |
| Lead Model Unknown | 1,253 | 46 | 1.6% |
| Vns Therapy Pulse | 1,064 | 0 | 10.7% |
| Ncp Bipolar Lead | 746 | 0 | 0% |
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 Symmetry Gen Model 8103 reports
How many FDA reports name Symmetry Gen Model 8103?
209 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 23 in the latest 12 months.
What kinds of events are reported?
injury (73.7%), malfunction (22.5%) and death (3.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
premature discharge of battery (3.3%), insufficient device problem information (2.4%), erratic or intermittent display (1.4%), high impedance (1.4%) and electrostatic discharge (1%). 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 Symmetry Gen Model 8103 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.