Devices › Stimulator, electrical, implanted, for parkinsonian tremor
Device brand name · Stimulator electrical implanted for parkinsonian tremor
Activa Pc: medical device reports filed with FDA
409 reports name it, 2009–2016. Manufacturer given most often on reports: Mdt Puerto Rico Operations Juncos. Product code MHY.
- 409
- device reports naming the brand
- 0% of all MAUDE reports · about 24 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 57%
- classified as malfunction
- 50.2% across the product code
- 1.2%
- classified as death, as reported
- 5 reports · not verified by FDA
FDA's MAUDE database holds 409 reports that name the brand "Activa Pc" (stimulator electrical implanted for parkinsonian tremor), received between March 2009 and October 2016; the manufacturer given most often on reports is Mdt Puerto Rico Operations Juncos. 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 malfunction (57%), injury (41.8%) and death (1.2%); 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 high impedance (17.1%), device operates differently than expected (10.3%) and low impedance (9.3%). The patient problems coded most often are therapeutic response, decreased, electric shock and pain. 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 Activa Pc was received in the five years to August 2026; the latest was received in October 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 |
|---|---|---|---|
| High impedance | 70 | 17.1% | 13.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 42 | 10.3% | 9.4% |
| Low impedance | 38 | 9.3% | 4.9% |
| Insufficient device problem information | 29 | 7.1% | 5.4% |
| Premature discharge of battery | 23 | 5.6% | 2.7% |
| Impedance problem | 21 | 5.1% | 2.2% |
| Inappropriate/inadequate shock/stimulation | 21 | 5.1% | 4.6% |
| Device inoperablethe device could not be used | 20 | 4.9% | 0.2% |
| Electronic property issue | 20 | 4.9% | 0.2% |
| Electromagnetic interference | 19 | 4.6% | 1.9% |
| Migration or expulsion of device | 13 | 3.2% | 2.7% |
| Fracturea broken bone | 8 | 2% | 0.9% |
| Battery problema problem with the battery | 7 | 1.7% | 7.2% |
| Connection problema connection problem | 7 | 1.7% | 5.4% |
| Device displays incorrect message | 7 | 1.7% | 2.7% |
| Electrical shorting | 7 | 1.7% | 0.1% |
| Fitting problem | 6 | 1.5% | 0% |
| Breakthe device broke | 5 | 1.2% | 4.6% |
| Misconnection | 5 | 1.2% | 0% |
| Blocked connection | 4 | 1% | 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 |
|---|---|---|
| Therapeutic response, decreased | 83 | 20.3% |
| Electric shockan electric shock | 21 | 5.1% |
| Painpain, site not specified | 16 | 3.9% |
| Therapeutic effects, unexpected | 12 | 2.9% |
| Pocket erosion | 11 | 2.7% |
| Tingling | 8 | 2% |
| Complaint, ill-defined | 7 | 1.7% |
| Erosion | 5 | 1.2% |
| Muscular rigidity | 5 | 1.2% |
| Undesired nerve stimulation | 4 | 1% |
| Device embedded in tissue or plaque | 3 | 0.7% |
| Headachehead pain | 3 | 0.7% |
| Muscle spasm(s) | 3 | 0.7% |
| Seizures | 3 | 0.7% |
| Shaking/tremors | 3 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Activa Pc | Product code MHY | All MAUDE reports |
|---|---|---|---|
| Reports | 409 | 53,252 | 26,136,888 |
| Share of that pool | — | 0.8% | 0% |
| Classified as death, per 1,000 reports | 12 | 14 | 9 |
| Classified as injury | 41.8% | 47.9% | 36.2% |
| Classified as malfunction | 57% | 50.2% | 62.3% |
| Filed by the manufacturer | 99% | 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% |
| 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 Activa Pc reports
How many FDA reports name Activa Pc?
409 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?
malfunction (57%), injury (41.8%) and death (1.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
high impedance (17.1%), device operates differently than expected (10.3%), low impedance (9.3%), insufficient device problem information (7.1%) and premature discharge of battery (5.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Activa Pc 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.