Devices › Stimulator, electrical, implanted, for parkinsonian tremor
Device brand name · Lead
Dbs: medical device reports filed with FDA
239 reports name it, 1999–2019. Manufacturer given most often on reports: Medtronic Puerto Rico Operations. Product code MHY.
- 239
- device reports naming the brand
- 0% of all MAUDE reports · about 9 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 23.8%
- classified as malfunction
- 50.2% across the product code
- 2.9%
- classified as death, as reported
- 7 reports · not verified by FDA
239 medical device reports received by FDA name the brand "Dbs" (lead); the manufacturer given most often on reports is Medtronic Puerto Rico Operations; received from February 1999 to October 2019. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (56.1%), malfunction (23.8%) and other (16.7%); 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 (36.8%), explanted (20.5%) and other (for use when an appropriate device code cannot be identified) (9.6%). The patient problems coded most often are surgical procedure, treatment with medication(s) and hospitalization required. 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 Dbs was received in the five years to August 2026; the latest was received in October 2019.
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 | 88 | 36.8% | 1.2% |
| Explanted | 49 | 20.5% | 1.1% |
| Other (for use when an appropriate device code cannot be identified) | 23 | 9.6% | 0.5% |
| Replace | 18 | 7.5% | 1% |
| High impedance | 17 | 7.1% | 13.8% |
| Lead(s), breakage of | 8 | 3.3% | 0.2% |
| Wire(s), breakage of | 8 | 3.3% | 0.2% |
| Tears, rips, holes in device, device material | 7 | 2.9% | 0% |
| Performance | 6 | 2.5% | 0% |
| Device, or device fragments remain in patient | 5 | 2.1% | 0.1% |
| Migration or expulsion of device | 5 | 2.1% | 2.7% |
| Electro-magnetic interference (emi), compatibility/incompatibility | 3 | 1.3% | 0.1% |
| Reactiona reaction, type not specified | 3 | 1.3% | 0% |
| Suspect emi | 3 | 1.3% | 0.1% |
| Bent | 2 | 0.8% | 0.8% |
| Breakthe device broke | 2 | 0.8% | 4.6% |
| Dislodged | 2 | 0.8% | 0% |
| Implant extrusion | 2 | 0.8% | 0% |
| Insufficient device problem information | 2 | 0.8% | 5.4% |
| Insulation degradation | 2 | 0.8% | 0% |
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 |
|---|---|---|
| Surgical procedure | 51 | 21.3% |
| Treatment with medication(s) | 39 | 16.3% |
| Hospitalization required | 34 | 14.2% |
| Therapeutic response, decreased | 30 | 12.6% |
| Therapy/non-surgical treatment, additional | 28 | 11.7% |
| Neurological deficit/dysfunction | 25 | 10.5% |
| Other (for use when an appropriate patient code cannot be identified) | 17 | 7.1% |
| Cognitive changes | 14 | 5.9% |
| Therapeutic effects, unexpected | 13 | 5.4% |
| Drainage | 12 | 5% |
| Falla fall | 12 | 5% |
| Painpain, site not specified | 12 | 5% |
| Emotional changes | 10 | 4.2% |
| Swellingswelling | 10 | 4.2% |
| Confusion/ disorientation | 9 | 3.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Dbs | Product code MHY | All MAUDE reports |
|---|---|---|---|
| Reports | 239 | 53,252 | 26,136,888 |
| Share of that pool | — | 0.4% | 0% |
| Classified as death, per 1,000 reports | 29 | 14 | 9 |
| Classified as injury | 56.1% | 47.9% | 36.2% |
| Classified as malfunction | 23.8% | 50.2% | 62.3% |
| Filed by the manufacturer | 98.7% | 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% |
| 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% |
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 Dbs reports
How many FDA reports name Dbs?
239 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 (56.1%), malfunction (23.8%) and other (16.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device remains implanted (36.8%), explanted (20.5%), other (for use when an appropriate device code cannot be identified) (9.6%), replace (7.5%) and high impedance (7.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Dbs 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.