Devices › Stimulator, electrical, implanted, for parkinsonian tremor
Device brand name · Stimulator electrical implanted for parkinsonian tremor
Deep Brain Stimulation Lead: medical device reports filed with FDA
754 reports name it, 2007–2016. Manufacturer given most often on reports: Medtronic Neuromodulation. Product code MHY.
- 754
- device reports naming the brand
- 0% of all MAUDE reports · about 40 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 32.1%
- classified as malfunction
- 50.2% across the product code
- 3.8%
- classified as death, as reported
- 29 reports · not verified by FDA
FDA's MAUDE database holds 754 reports that name the brand "Deep Brain Stimulation Lead" (stimulator electrical implanted for parkinsonian tremor), received between June 2007 and March 2016; the manufacturer given most often on reports is Medtronic Neuromodulation. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 (63.8%), malfunction (32.1%) and death (3.8%); across all stimulator, electrical, implanted, for parkinsonian tremor reports (product code MHY) death is recorded in 1.4% and malfunction in 50.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device remains implanted (17.2%), other (for use when an appropriate device code cannot be identified) (17.1%) and high impedance (10.5%). The patient problems coded most often are therapeutic response, decreased, surgical procedure and therapeutic effects, unexpected. 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
No report naming Deep Brain Stimulation Lead was received in the five years to August 2026; the latest was received in March 2016.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 53,252 reports carrying product code MHY. 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 |
|---|---|---|---|
| Device remains implanted | 130 | 17.2% | 1.2% |
| Other (for use when an appropriate device code cannot be identified) | 129 | 17.1% | 0.5% |
| High impedance | 79 | 10.5% | 13.8% |
| Replace | 42 | 5.6% | 1% |
| Bent | 39 | 5.2% | 0.8% |
| Lead(s), breakage of | 33 | 4.4% | 0.2% |
| Explanted | 28 | 3.7% | 1.1% |
| Positioning problem | 21 | 2.8% | 0.5% |
| Migration or expulsion of device | 19 | 2.5% | 2.7% |
| Device remains activated | 17 | 2.3% | 0.1% |
| Device, or device fragments remain in patient | 16 | 2.1% | 0.1% |
| Kinkedthe tube or line kinked | 16 | 2.1% | 0.1% |
| Low impedance | 11 | 1.5% | 4.9% |
| Device operates differently than expectedthe device behaved unexpectedly | 10 | 1.3% | 9.4% |
| Implant, removal of | 9 | 1.2% | 0.1% |
| Implant, repositioning of | 9 | 1.2% | 0.1% |
| Lead(s), fracture of | 9 | 1.2% | 0% |
| Misplacement | 9 | 1.2% | 0% |
| Tears, rips, holes in device, device material | 8 | 1.1% | 0% |
| Breakthe device broke | 7 | 0.9% | 4.6% |
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 |
|---|---|---|
| Therapeutic response, decreased | 100 | 13.3% |
| Surgical procedure | 82 | 10.9% |
| Therapeutic effects, unexpected | 55 | 7.3% |
| Emotional changes | 51 | 6.8% |
| Dysphasia | 37 | 4.9% |
| Cognitive changes | 35 | 4.6% |
| Intracranial hemorrhage | 32 | 4.2% |
| Depressionlow mood | 29 | 3.8% |
| Treatment with medication(s) | 28 | 3.7% |
| Deaththe patient died; cause not stated by this term | 26 | 3.4% |
| Ambulation or postural difficulties | 25 | 3.3% |
| Neurological deficit/dysfunction | 25 | 3.3% |
| Seizures | 25 | 3.3% |
| Dyskinesiainvoluntary movements | 20 | 2.7% |
| Falla fall | 20 | 2.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Deep Brain Stimulation Lead | Product code MHY | All MAUDE reports |
|---|---|---|---|
| Reports | 754 | 53,252 | 26,136,888 |
| Share of that pool | — | 1.4% | 0% |
| Classified as death, per 1,000 reports | 38 | 14 | 9 |
| Classified as injury | 63.8% | 47.9% | 36.2% |
| Classified as malfunction | 32.1% | 50.2% | 62.3% |
| Filed by the manufacturer | 100% | 99.6% | 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 MHY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Activa | 30,012 | 1,112 | 0.6% |
| Soletra | 4,710 | 12 | 4.2% |
| Percept | 4,041 | 1,239 | 0.3% |
| Implantable Neurostimulator | 6,395 | 692 | 0.3% |
| Kinetra | 2,276 | 1 | 2.1% |
| Unknown Implantable Neurostimulator | 3,843 | 0 | 2.2% |
| Infinity 7 Implantable Pulse Generator | 1,258 | 147 | 0.5% |
| 8CH Infinity DBS Lead Kit, 40cm, 0.5, B | 1,128 | 92 | 1.3% |
| 8CH Infinity DBS Flex Extn Kit, 50cm, B | 738 | 142 | 0% |
| Sensight | 763 | 250 | 1.6% |
| 8CH Infinity DBS Flex Extn Kit, 60cm, B | 571 | 120 | 0% |
| Unknown Deep Brain Stimulator | 569 | 0 | 4.9% |
| Activa Pc | 409 | 0 | 1.2% |
| External Neurostimulator | 1,227 | 102 | 0.4% |
| Vercise Genus | 1,014 | 338 | 2.4% |
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 Deep Brain Stimulation Lead reports
How many FDA reports name Deep Brain Stimulation Lead?
754 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (63.8%), malfunction (32.1%) and death (3.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device remains implanted (17.2%), other (for use when an appropriate device code cannot be identified) (17.1%), high impedance (10.5%), replace (5.6%) and bent (5.2%). 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 Deep Brain Stimulation Lead 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.