Devices › Stimulator, electrical, implanted, for parkinsonian symptoms
Device brand name · Stimulator electrical implanted for parkinsonian symptoms
Vercise? Cartesia?: medical device reports filed with FDA
908 reports name it, 2018–2026. Manufacturer given most often on reports: Boston Scientific Neuromodulation. Product code NHL.
- 908
- device reports naming the brand
- 0% of all MAUDE reports · about 108 a year
- 132
- reports, 12 months to August 2026
- 151 in the 12 months before
- 2.5%
- classified as malfunction
- 9.9% across the product code
- 2.4%
- classified as death, as reported
- 22 reports · not verified by FDA
FDA's MAUDE database holds 908 reports that name the brand "Vercise? Cartesia?" (stimulator electrical implanted for parkinsonian symptoms), received between February 2018 and August 2026; the manufacturer given most often on reports is Boston Scientific Neuromodulation. Spellings of one product vary from report to report.
132 reports arrived in the 12 months to August 2026, down 13% from 151 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 (95%), malfunction (2.5%) and death (2.4%); across all stimulator, electrical, implanted, for parkinsonian symptoms reports (product code NHL) death is recorded in 2.3% and malfunction in 9.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are unexpected therapeutic results (20.7%), migration (10%) and high impedance (6.9%). The patient problems coded most often are swelling/ edema, shaking/tremors and bacterial 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 1,824 reports carrying product code NHL. 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 |
|---|---|---|---|
| Unexpected therapeutic results | 188 | 20.7% | 18.3% |
| Migrationthe device moved from where it was placed | 91 | 10% | 7.5% |
| High impedance | 63 | 6.9% | 8.3% |
| Fracturea broken bone | 16 | 1.8% | 1.6% |
| Inappropriate/inadequate shock/stimulation | 10 | 1.1% | 2.3% |
| Low impedance | 8 | 0.9% | 0.5% |
| Off-label use | 8 | 0.9% | 0.9% |
| Defective devicethe device was defective | 6 | 0.7% | 0.8% |
| Failure to disconnect | 6 | 0.7% | 0.2% |
| Positioning problem | 5 | 0.6% | 0.4% |
| Difficult to removethe device was hard to remove | 4 | 0.4% | 0% |
| Material twisted/bent | 4 | 0.4% | 0.2% |
| Nonstandard device | 4 | 0.4% | 0.5% |
| Unintended movement | 4 | 0.4% | 0.2% |
| Communication or transmission problemthe device could not communicate or transmit | 1 | 0.1% | 0.1% |
| Device contaminated during manufacture or shipping | 1 | 0.1% | 0% |
| Device dislodged or dislocated | 1 | 0.1% | 0.1% |
| Difficult to insertthe device was hard to insert | 1 | 0.1% | 0% |
| Difficult to open or close | 1 | 0.1% | 0% |
| Human-device interface problem | 1 | 0.1% | 0.1% |
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 |
|---|---|---|
| Swelling/ edema | 109 | 12% |
| Shaking/tremors | 91 | 10% |
| Bacterial infectiona bacterial infection | 88 | 9.7% |
| Erosion | 80 | 8.8% |
| Intracranial hemorrhage | 53 | 5.8% |
| Wound dehiscencea wound reopened | 52 | 5.7% |
| Movement disorder | 49 | 5.4% |
| Hemorrhage/blood loss/bleeding | 45 | 5% |
| Impaired healingslow healing | 45 | 5% |
| Convulsion/seizure | 42 | 4.6% |
| Inflammationinflammation | 42 | 4.6% |
| Speech disordera speech problem | 42 | 4.6% |
| Inadequate pain relief | 37 | 4.1% |
| Painpain, site not specified | 37 | 4.1% |
| Confusion/ disorientation | 35 | 3.9% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Vercise? Cartesia? | Product code NHL | All MAUDE reports |
|---|---|---|---|
| Reports | 908 | 1,824 | 26,136,888 |
| Share of that pool | — | 49.8% | 0% |
| Classified as death, per 1,000 reports | 24 | 23 | 9 |
| Classified as injury | 95% | 87.7% | 36.2% |
| Classified as malfunction | 2.5% | 9.9% | 62.3% |
| Filed by the manufacturer | 100% | 97.3% | 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 NHL
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Vercise Genus | 1,014 | 338 | 2.4% |
| Vercise Gevia? | 355 | 26 | 2.3% |
| Vercise | 274 | 43 | 0.4% |
| Vercise Pc | 156 | 15 | 1.3% |
| SureTek? | 151 | 31 | 0% |
| Infinity 7 Implantable Pulse Generator | 1,258 | 147 | 0.5% |
| Infinity 5 Implantable Pulse Generator | 320 | 22 | 0.6% |
| Dbs | 239 | 0 | 2.9% |
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 Vercise? Cartesia? reports
How many FDA reports name Vercise? Cartesia??
908 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 132 in the latest 12 months.
What kinds of events are reported?
injury (95%), malfunction (2.5%) and death (2.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
unexpected therapeutic results (20.7%), migration (10%), high impedance (6.9%), fracture (1.8%) and inappropriate/inadequate shock/stimulation (1.1%). 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 Vercise? Cartesia? 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.