Stimulator, autonomic nerve, implanted (depression): medical device reports filed with FDA

2,368 reports carry this product code, 2004–2026; 24 brands with a page.

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.

2,368
reports with this product code: 0% of all MAUDE reports; 37
reports, 12 months to August 2026: 62 in the 12 months before; 48.9%
classified as malfunction: 62.3% across all reports; 3.3%
classified as death, as reported: 0.9% across all reports

Product code MUZ is FDA's classification for "Stimulator, autonomic nerve, implanted (depression)" (unknown panel), a class 3 device. 2,368 medical device reports carry this product code, 0% of the MAUDE database, from August 2004 to August 2026.

37 reports arrived in the 12 months to August 2026, down 40% from 62 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 (48.9%), injury (47.2%) and death (3.3%). 24 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Pulse Gen Model 102	714	14	12.2%	25.8%
Lead Model 302	358	136	0%	91.9%
Programming Software	316	1	0%	99.3%
Symmetry Gen Model 8103	197	23	3.8%	22.5%
Pulse Gen Model 103	96	34	8.5%	29.8%
Pulse Gen Model Unk	74	7	13.6%	25.8%
Bipol Lead Model 300	69	12	0.1%	92.7%
Lead Model 304	67	272	0.1%	74.2%
Programming Wand	51	0	0%	99.7%
Pulse Gen Model 106	38	144	5.1%	39.6%
Pulse Gen Model 105	32	7	6.7%	32.5%
Pulse Gen Model 1000	31	549	5.7%	38.9%
Lead Model 303	26	28	0%	66.5%
Lead Model Unknown	20	46	1.6%	83.4%
Vns Therapy Pulse	19	0	10.7%	18.3%
Ncp Bipolar Lead	17	0	0%	83.5%
Bipol Lead Model 302	16	0	0%	81.5%
Pulse Gen Model 101	13	0	12.6%	41.8%
Pulse Gen Model unknown	13	40	10.9%	22.1%
Lead Model Unk	8	0	0.3%	80.6%
Pulse Gen Model 102r	7	0	10.9%	26.6%
Pulse Gen Model 104	5	4	9%	35%
Lead Model 300	4	22	0%	93.9%
Vns Therapy Lead	4	0	0%	50.2%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Cyberonics	1,569	66.3%
Livanova USA	527	22.3%
Cyberonics - Houston	244	10.3%
Houston	21	0.9%

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 and report source

Event type

Death3.3%77

Injury47.2%1,118

Malfunction48.9%1,159

Other0.3%8

Not given0.3%6

Who filed

Manufacturer report99.1%2,347

Voluntary report0.7%17

User facility report0%0

Distributor report0%0

Not given0.2%4

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
High impedance	294	12.4%
Insufficient device problem information	263	11.1%
Device remains implanted	253	10.7%
Fracturea broken bone	114	4.8%
Explanted	83	3.5%
Device operates differently than expectedthe device behaved unexpectedly	81	3.4%
Failure to interrogate	68	2.9%
Use of incorrect control/treatment settings	63	2.7%
Replace	56	2.4%
No display/image	49	2.1%
Battery problema problem with the battery	40	1.7%
Repair	37	1.6%
Programming issue	34	1.4%
Communication or transmission problemthe device could not communicate or transmit	33	1.4%
Device displays incorrect message	33	1.4%
Migration or expulsion of device	32	1.4%
Computer failure	22	0.9%
Device inoperablethe device could not be used	22	0.9%
Failure of device to self-test	22	0.9%
Premature discharge of battery	20	0.8%

Questions about stimulator, autonomic nerve, implanted (depression) reports

What is product code MUZ?

FDA's classification code for "Stimulator, autonomic nerve, implanted (depression)", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,368 reports through August 2026, 37 of them in the latest 12 months.

Which brands appear most often?

Pulse Gen Model 102 (714), Lead Model 302 (358), Programming Software (316), Symmetry Gen Model 8103 (197) and Pulse Gen Model 103 (96). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.