Devices › Stimulator, electrical, implanted, for parkinsonian tremor
Device brand name · Dbs lead
8CH Infinity DBS Lead Kit, 40cm, 0.5, B: medical device reports filed with FDA
1,128 reports name it, 2017–2026. Manufacturer given most often on reports: St Jude Medical - Neuromodulation. Product code MHY.
- 1,128
- device reports naming the brand
- 0% of all MAUDE reports · about 119 a year
- 92
- reports, 12 months to August 2026
- 54 in the 12 months before
- 55.1%
- classified as malfunction
- 50.2% across the product code
- 1.3%
- classified as death, as reported
- 15 reports · not verified by FDA
1,128 medical device reports received by FDA name the brand "8CH Infinity DBS Lead Kit, 40cm, 0.5, B" (dbs lead); the manufacturer given most often on reports is St Jude Medical - Neuromodulation; received from January 2017 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
92 reports arrived in the 12 months to August 2026, up 70% from 54 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 (55.1%), injury (43.5%) and death (1.3%); 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 component misassembled (55.1%), therapeutic or diagnostic output failure (8%) and high impedance (3.7%). The patient problems coded most often are inadequate pain relief, movement disorder and post operative wound infection. 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 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 |
|---|---|---|---|
| Component misassembled | 621 | 55.1% | 1.5% |
| Therapeutic or diagnostic output failure | 90 | 8% | 1.2% |
| High impedance | 42 | 3.7% | 13.8% |
| Migrationthe device moved from where it was placed | 31 | 2.7% | 0.4% |
| Impedance problem | 13 | 1.2% | 2.2% |
| Malposition of device | 12 | 1.1% | 1.9% |
| Fracturea broken bone | 9 | 0.8% | 0.9% |
| Low impedance | 8 | 0.7% | 4.9% |
| Insufficient device problem information | 7 | 0.6% | 5.4% |
| Inappropriate/inadequate shock/stimulation | 4 | 0.4% | 4.6% |
| Improper or incorrect procedure or method | 3 | 0.3% | 1.2% |
| Positioning problem | 3 | 0.3% | 0.5% |
| Electromagnetic interference | 2 | 0.2% | 1.9% |
| Material twisted/bent | 2 | 0.2% | 0.7% |
| No device output | 2 | 0.2% | 0.4% |
| Patient-device incompatibilitythe device did not suit the patient | 2 | 0.2% | 0% |
| Accessory incompatible | 1 | 0.1% | 0% |
| Activation, positioning or separation problem | 1 | 0.1% | 0.2% |
| Disconnection | 1 | 0.1% | 0.3% |
| Failure to deliver energy | 1 | 0.1% | 5.7% |
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 |
|---|---|---|
| Inadequate pain relief | 114 | 10.1% |
| Movement disorder | 75 | 6.6% |
| Post operative wound infection | 46 | 4.1% |
| Erosion | 34 | 3% |
| Wound dehiscencea wound reopened | 16 | 1.4% |
| Deaththe patient died; cause not stated by this term | 11 | 1% |
| Skin erosion | 10 | 0.9% |
| Failure of implant | 9 | 0.8% |
| Hemorrhage/blood loss/bleeding | 8 | 0.7% |
| Falla fall | 7 | 0.6% |
| Fluid discharge | 7 | 0.6% |
| Hematomaa collection of blood under the skin or in tissue | 6 | 0.5% |
| Cognitive changes | 5 | 0.4% |
| Discomfortdiscomfort | 5 | 0.4% |
| Intracranial hemorrhage | 5 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | 8CH Infinity DBS Lead Kit, 40cm, 0.5, B | Product code MHY | All MAUDE reports |
|---|---|---|---|
| Reports | 1,128 | 53,252 | 26,136,888 |
| Share of that pool | — | 2.1% | 0% |
| Classified as death, per 1,000 reports | 13 | 14 | 9 |
| Classified as injury | 43.5% | 47.9% | 36.2% |
| Classified as malfunction | 55.1% | 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% |
| Deep Brain Stimulation Lead | 754 | 0 | 3.8% |
| 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 8CH Infinity DBS Lead Kit, 40cm, 0.5, B reports
How many FDA reports name 8CH Infinity DBS Lead Kit, 40cm, 0.5, B?
1,128 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 92 in the latest 12 months.
What kinds of events are reported?
malfunction (55.1%), injury (43.5%) and death (1.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
component misassembled (55.1%), therapeutic or diagnostic output failure (8%), high impedance (3.7%), migration (2.7%) and impedance problem (1.2%). 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 8CH Infinity DBS Lead Kit, 40cm, 0.5, B 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.