Stimulator, electrical, implanted, for parkinsonian tremor: medical device reports filed with FDA

53,252 reports carry this product code, 1999–2026; 30 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.

53,252
reports with this product code: 0.2% of all MAUDE reports; 3,380
reports, 12 months to August 2026: 3,372 in the 12 months before; 50.2%
classified as malfunction: 62.3% across all reports; 1.4%
classified as death, as reported: 0.9% across all reports

Product code MHY is FDA's classification for "Stimulator, electrical, implanted, for parkinsonian tremor" (unknown panel), a class 3 device. 53,252 medical device reports carry this product code, 0.2% of the MAUDE database, from April 1999 to August 2026.

3,380 reports arrived in the 12 months to August 2026, close to the 3,372 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 (50.2%), injury (47.9%) and death (1.4%). 30 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
Activa	26,242	1,112	0.6%	60.8%
Soletra	4,531	12	4.2%	48%
Percept	2,937	1,239	0.3%	58.6%
Implantable Neurostimulator	2,421	692	0.3%	63.6%
Kinetra	2,136	1	2.1%	37.3%
Unknown Implantable Neurostimulator	1,553	0	2.2%	29.3%
Infinity 7 Implantable Pulse Generator	1,233	147	0.5%	2.5%
8CH Infinity DBS Lead Kit, 40cm, 0.5, B	1,127	92	1.3%	55.1%
Deep Brain Stimulation Lead	753	0	3.8%	32.1%
8CH Infinity DBS Flex Extn Kit, 50cm, B	738	142	0%	0.7%
Sensight	683	250	1.6%	74.4%
8CH Infinity DBS Flex Extn Kit, 60cm, B	571	120	0%	1.2%
Unknown Deep Brain Stimulator	568	0	4.9%	17.2%
Activa Pc	409	0	1.2%	57%
External Neurostimulator	404	102	0.4%	52.4%
Vercise Genus	369	338	2.4%	17.2%
8CH Infinity DBS Lead Kit, 40cm, 1.5, B	313	40	1.6%	0%
Infinity 5 Implantable Pulse Generator	312	22	0.6%	3.1%
8ch Infinity Dbs Lead Kit 30cm 0 5 B	254	2	0%	80.3%
Vercise Gevia?	208	26	2.3%	2%
Unk Deep Brain Stimulator	202	0	4.5%	13.4%
Vercise	186	43	0.4%	7.7%
Dbs	179	0	2.9%	23.8%
Guardian Cranial Burr Hole Cover System	170	30	0%	0%
Unknown Neurostimulator	159	0	1.7%	49.6%
Vercise? Cartesia?	151	132	2.4%	2.5%
Infinity Ipg	137	0	0.6%	56%
Vercise Pc	137	15	1.3%	12.8%
SureTek?	133	31	0%	16.6%
Neu Ins Stimulator	128	0	2.1%	21.5%

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
Medtronic Puerto Rico Operations	15,164	28.5%
Medtronic Neuromodulation	11,496	21.6%
Medtronic Med Rel Medtronic Puerto Rico	8,310	15.6%
Abbott Medical	3,000	5.6%
St Jude Medical - Neuromodulation	1,918	3.6%
Boston Scientific Neuromodulation	1,450	2.7%
Mdt Puerto Rico Operations Juncos	1,380	2.6%
Mpri	1,294	2.4%
Neuro - Villalba	949	1.8%
Ipg Mfg Switzerland	737	1.4%
Medtronic Europe Sarl	707	1.3%
Mdt Puerto Rico Operations	689	1.3%
Medtronic Puerto Rico Villalba	318	0.6%
Medtronic Puerto Rico Operations Juncos	299	0.6%
St Jude Medical - Neuromodulation Puerto Rico	250	0.5%

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

Death1.4%734

Injury47.9%25,533

Malfunction50.2%26,754

Other0.4%194

Not given0.1%37

Who filed

Manufacturer report99.6%53,050

Voluntary report0.2%116

User facility report0%0

Distributor report0%1

Not given0.2%85

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

Device problems coded

Device problem (FDA code)	Reports	Share
High impedance	7,341	13.8%
Device operates differently than expectedthe device behaved unexpectedly	5,009	9.4%
Battery problema problem with the battery	3,851	7.2%
Failure to deliver energy	3,041	5.7%
Connection problema connection problem	2,901	5.4%
Insufficient device problem information	2,890	5.4%
Low impedance	2,585	4.9%
Charging problem	2,570	4.8%
Inappropriate/inadequate shock/stimulation	2,435	4.6%
Breakthe device broke	2,427	4.6%
Material integrity problema problem with the device material	2,373	4.5%
Communication or transmission problemthe device could not communicate or transmit	1,990	3.7%
Device displays incorrect message	1,464	2.7%
Migration or expulsion of device	1,435	2.7%
Premature discharge of battery	1,426	2.7%
Electromagnetic compatibility problem	1,258	2.4%
Impedance problem	1,171	2.2%
Unintended collision	1,154	2.2%
Malposition of device	1,005	1.9%
Electromagnetic interference	988	1.9%

Questions about stimulator, electrical, implanted, for parkinsonian tremor reports

What is product code MHY?

FDA's classification code for "Stimulator, electrical, implanted, for parkinsonian tremor", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

53,252 reports through August 2026, 3,380 of them in the latest 12 months.

Which brands appear most often?

Activa (26,242), Soletra (4,531), Percept (2,937), Implantable Neurostimulator (2,421) and Kinetra (2,136). 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.