Devices › Pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Device brand name · Pulse generator pacemaker implantable with cardiac resynchronization crt-p
Visionist X4 Crt-P: medical device reports filed with FDA
1,778 reports name it, 2019–2026. Manufacturer given most often on reports: Boston Scientific. Product code NKE.
- 1,778
- device reports naming the brand
- 0% of all MAUDE reports · about 237 a year
- 877
- reports, 12 months to August 2026
- 286 in the 12 months before
- 51%
- classified as malfunction
- 43.9% across the product code
- 0.2%
- classified as death, as reported
- 3 reports · not verified by FDA
FDA's MAUDE database holds 1,778 reports that name the brand "Visionist X4 Crt-P" (pulse generator pacemaker implantable with cardiac resynchronization crt-p), received between January 2019 and August 2026; the manufacturer given most often on reports is Boston Scientific. Spellings of one product vary from report to report.
877 reports arrived in the 12 months to August 2026, up 207% from 286 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 (51%), injury (48.9%) and death (0.2%); across all pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) reports (product code NKE) death is recorded in 1.9% and malfunction in 43.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are premature discharge of battery (38.4%), incorrect, inadequate or imprecise result or readings (14.8%) and over-sensing (13.9%). The patient problems coded most often are device overstimulation of tissue, syncope/fainting and sepsis. 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 14,671 reports carrying product code NKE. 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 |
|---|---|---|---|
| Premature discharge of battery | 683 | 38.4% | 18.5% |
| Incorrect, inadequate or imprecise result or readings | 264 | 14.8% | 10.9% |
| Over-sensing | 248 | 13.9% | 10.4% |
| Pacing problem | 164 | 9.2% | 9% |
| Signal artifact/noise | 148 | 8.3% | 4.1% |
| High impedance | 144 | 8.1% | 6.2% |
| Failure to capture | 110 | 6.2% | 4.2% |
| Interrogation problem | 99 | 5.6% | 2.7% |
| Battery problema problem with the battery | 66 | 3.7% | 2.1% |
| Under-sensing | 59 | 3.3% | 1.6% |
| Failure to read input signal | 53 | 3% | 0.7% |
| Data problem | 52 | 2.9% | 1.6% |
| High capture threshold | 50 | 2.8% | 1.5% |
| Defective devicethe device was defective | 42 | 2.4% | 2.3% |
| Low impedance | 28 | 1.6% | 1.7% |
| Off-label use | 21 | 1.2% | 0.6% |
| Insufficient device problem information | 17 | 1% | 1.3% |
| Impedance problem | 15 | 0.8% | 0.9% |
| Device sensing problem | 11 | 0.6% | 1.3% |
| Telemetry discrepancy | 10 | 0.6% | 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 |
|---|---|---|
| Device overstimulation of tissue | 50 | 2.8% |
| Syncope/fainting | 38 | 2.1% |
| Sepsisa severe body-wide response to infection | 37 | 2.1% |
| Asystole | 32 | 1.8% |
| Pocket erosion | 22 | 1.2% |
| Bradycardiaslow heart rate | 21 | 1.2% |
| Dizzinesslight-headedness or unsteadiness | 19 | 1.1% |
| Bacterial infectiona bacterial infection | 12 | 0.7% |
| Discomfortdiscomfort | 12 | 0.7% |
| Dyspneashortness of breath | 12 | 0.7% |
| Falla fall | 11 | 0.6% |
| Presyncope | 10 | 0.6% |
| Hematomaa collection of blood under the skin or in tissue | 8 | 0.4% |
| Loss of consciousnesspassing out | 7 | 0.4% |
| Painpain, site not specified | 6 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Visionist X4 Crt-P | Product code NKE | All MAUDE reports |
|---|---|---|---|
| Reports | 1,778 | 14,671 | 26,136,888 |
| Share of that pool | — | 12.1% | 0% |
| Classified as death, per 1,000 reports | 2 | 19 | 9 |
| Classified as injury | 48.9% | 54.1% | 36.2% |
| Classified as malfunction | 51% | 43.9% | 62.3% |
| Filed by the manufacturer | 99.9% | 98.9% | 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 NKE
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Valitude X4 Crt-P | 2,133 | 834 | 0.8% |
| Percepta Quad CRT-P MRI SureScan | 1,539 | 261 | 2.3% |
| Quadra Allure MP CRT-P | 1,291 | 205 | 2.2% |
| Invive | 959 | 4 | 0.1% |
| Visionist Crt-P | 623 | 278 | 0.6% |
| Valitude Crt-P | 595 | 221 | 0.3% |
| Percepta CRT-P MRI SureScan | 549 | 97 | 1.3% |
| Accolade | 4,335 | 4 | 1.5% |
| Quadra Allure MP RF CRT-P | 765 | 17 | 6.1% |
| Contak Renewal Tr | 489 | 0 | 3.5% |
| Percepta Quad Crtp | 329 | 0 | 0% |
| Anthem Rf Crt-P | 300 | 0 | 7.3% |
| Solara Quad CRT-P MRI SureScan | 273 | 40 | 2.2% |
| Allure Quadra RF CRT-P | 680 | 6 | 5.9% |
| Intua | 253 | 5 | 0% |
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 Visionist X4 Crt-P reports
How many FDA reports name Visionist X4 Crt-P?
1,778 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 877 in the latest 12 months.
What kinds of events are reported?
malfunction (51%), injury (48.9%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
premature discharge of battery (38.4%), incorrect, inadequate or imprecise result or readings (14.8%), over-sensing (13.9%), pacing problem (9.2%) and signal artifact/noise (8.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Visionist X4 Crt-P 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.