Implanted subcortical electrical stimulator (motor disorders): medical device reports filed with FDA

2,925 reports carry this product code, 2001–2026; 8 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.

2,925
reports with this product code: 0% of all MAUDE reports; 217
reports, 12 months to August 2026: 201 in the 12 months before; 53.8%
classified as malfunction: 62.3% across all reports; 0.5%
classified as death, as reported: 0.9% across all reports

Product code MRU is FDA's classification for "Implanted subcortical electrical stimulator (motor disorders)" (unknown panel), a class f device. 2,925 medical device reports carry this product code, 0% of the MAUDE database, from November 2001 to August 2026.

217 reports arrived in the 12 months to August 2026, close to the 201 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 (53.8%), injury (45.6%) and death (0.5%). 8 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	1,981	1,112	0.6%	60.8%
Percept	186	1,239	0.3%	58.6%
Soletra	154	12	4.2%	48%
Unknown Implantable Neurostimulator	96	0	2.2%	29.3%
Kinetra	71	1	2.1%	37.3%
Implantable Neurostimulator	50	692	0.3%	63.6%
Restore	5	27	0.1%	49.4%
Unknown Deep Brain Stimulator	1	0	4.9%	17.2%

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
Medtronic Neuromodulation	633	21.6%
Medtronic Med Rel Medtronic Puerto Rico	559	19.1%
Neuro - Villalba	34	1.2%
Ipg Mfg Switzerland	21	0.7%
Mdt Puerto Rico Operations	7	0.2%
Medtronic Europe Sarl	1	0%

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

Death0.5%16

Injury45.6%1,334

Malfunction53.8%1,574

Other0%0

Not given0%1

Who filed

Manufacturer report99.5%2,911

Voluntary report0.4%11

User facility report0%0

Distributor report0%0

Not given0.1%3

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

Device problems coded

Device problem (FDA code)	Reports	Share
High impedance	407	13.9%
Battery problema problem with the battery	317	10.8%
Failure to deliver energy	296	10.1%
Charging problem	284	9.7%
Device operates differently than expectedthe device behaved unexpectedly	274	9.4%
Connection problema connection problem	265	9.1%
Material integrity problema problem with the device material	228	7.8%
Communication or transmission problemthe device could not communicate or transmit	184	6.3%
Breakthe device broke	175	6%
Insufficient device problem information	167	5.7%
Low impedance	154	5.3%
Migration or expulsion of device	147	5%
Inappropriate/inadequate shock/stimulation	125	4.3%
Malposition of device	110	3.8%
Device displays incorrect message	103	3.5%
Impedance problem	97	3.3%
Improper or incorrect procedure or method	93	3.2%
Electromagnetic compatibility problem	87	3%
Low battery	80	2.7%
Premature discharge of battery	70	2.4%

Questions about implanted subcortical electrical stimulator (motor disorders) reports

What is product code MRU?

FDA's classification code for "Implanted subcortical electrical stimulator (motor disorders)", class f, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,925 reports through August 2026, 217 of them in the latest 12 months.

Which brands appear most often?

Activa (1,981), Percept (186), Soletra (154), Unknown Implantable Neurostimulator (96) and Kinetra (71). 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.