Devices › Stimulator, electrical, implanted, for parkinsonian tremor
Device brand name · Stimulator electrical implanted for parkinsonian tremor
Soletra: medical device reports filed with FDA
4,710 reports name it, 2001–2026. Manufacturer given most often on reports: Medtronic Med Rel Medtronic Puerto Rico. Product code MHY.
- 4,710
- device reports naming the brand
- 0% of all MAUDE reports · about 191 a year
- 12
- reports, 12 months to August 2026
- 3 in the 12 months before
- 48%
- classified as malfunction
- 50.2% across the product code
- 4.2%
- classified as death, as reported
- 197 reports · not verified by FDA
FDA's MAUDE database holds 4,710 reports that name the brand "Soletra" (stimulator electrical implanted for parkinsonian tremor), received between November 2001 and July 2026; the manufacturer given most often on reports is Medtronic Med Rel Medtronic Puerto Rico. Spellings of one product vary from report to report.
12 reports arrived in the 12 months to August 2026, up 300% from 3 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 (48%), injury (45.1%) and death (4.2%); 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 operates differently than expected (16.1%), high impedance (12.1%) and inappropriate/inadequate shock/stimulation (8.3%). The patient problems coded most often are therapeutic response, decreased, electric shock 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
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 |
|---|---|---|---|
| Device operates differently than expectedthe device behaved unexpectedly | 758 | 16.1% | 9.4% |
| High impedance | 571 | 12.1% | 13.8% |
| Inappropriate/inadequate shock/stimulation | 391 | 8.3% | 4.6% |
| Electromagnetic interference | 292 | 6.2% | 1.9% |
| Insufficient device problem information | 275 | 5.8% | 5.4% |
| Explanted | 255 | 5.4% | 1.1% |
| Failure to deliver energy | 231 | 4.9% | 5.7% |
| Device remains implanted | 220 | 4.7% | 1.2% |
| Replace | 217 | 4.6% | 1% |
| Premature discharge of battery | 185 | 3.9% | 2.7% |
| Intermittent continuity | 184 | 3.9% | 1.5% |
| Electromagnetic compatibility problem | 148 | 3.1% | 2.4% |
| Low impedance | 140 | 3% | 4.9% |
| Low battery | 139 | 3% | 1.8% |
| Breakthe device broke | 126 | 2.7% | 4.6% |
| Migration or expulsion of device | 109 | 2.3% | 2.7% |
| Loss of powerthe device lost power | 99 | 2.1% | 0.3% |
| Device stops intermittentlythe device stopped now and then | 92 | 2% | 0.3% |
| Battery problema problem with the battery | 83 | 1.8% | 7.2% |
| Device displays incorrect message | 83 | 1.8% | 2.7% |
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 |
|---|---|---|
| Therapeutic response, decreased | 1,264 | 26.8% |
| Electric shockan electric shock | 418 | 8.9% |
| Therapeutic effects, unexpected | 356 | 7.6% |
| Surgical procedure | 295 | 6.3% |
| Shaking/tremors | 283 | 6% |
| Complaint, ill-defined | 248 | 5.3% |
| Ambulation or postural difficulties | 195 | 4.1% |
| Deaththe patient died; cause not stated by this term | 187 | 4% |
| Painpain, site not specified | 186 | 3.9% |
| Falla fall | 178 | 3.8% |
| Surgical procedure, additional | 127 | 2.7% |
| Tingling | 106 | 2.3% |
| Muscular rigidity | 97 | 2.1% |
| Identified diagnosis | 95 | 2% |
| Dysphasia | 92 | 2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Soletra | Product code MHY | All MAUDE reports |
|---|---|---|---|
| Reports | 4,710 | 53,252 | 26,136,888 |
| Share of that pool | — | 8.8% | 0% |
| Classified as death, per 1,000 reports | 42 | 14 | 9 |
| Classified as injury | 45.1% | 47.9% | 36.2% |
| Classified as malfunction | 48% | 50.2% | 62.3% |
| Filed by the manufacturer | 99.9% | 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% |
| 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% |
| 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 Soletra reports
How many FDA reports name Soletra?
4,710 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 12 in the latest 12 months.
What kinds of events are reported?
malfunction (48%), injury (45.1%) and death (4.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device operates differently than expected (16.1%), high impedance (12.1%), inappropriate/inadequate shock/stimulation (8.3%), electromagnetic interference (6.2%) and insufficient device problem information (5.8%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Soletra 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.