Devices › Pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Device brand name · Pulse generator pacemaker implantable with cardiac resynchronization crt-p
Visionist Crt-P: medical device reports filed with FDA
623 reports name it, 2019–2026. Manufacturer given most often on reports: Boston Scientific. Product code NKE.
- 623
- device reports naming the brand
- 0% of all MAUDE reports · about 84 a year
- 278
- reports, 12 months to August 2026
- 85 in the 12 months before
- 52.6%
- classified as malfunction
- 43.9% across the product code
- 0.6%
- classified as death, as reported
- 4 reports · not verified by FDA
623 medical device reports received by FDA name the brand "Visionist Crt-P" (pulse generator pacemaker implantable with cardiac resynchronization crt-p); the manufacturer given most often on reports is Boston Scientific; received from February 2019 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
278 reports arrived in the 12 months to August 2026, up 227% from 85 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 (52.6%), injury (46.7%) and death (0.6%); 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 (40.8%), incorrect, inadequate or imprecise result or readings (16.4%) and over-sensing (14.3%). The patient problems coded most often are syncope/fainting, asystole and device overstimulation of tissue. 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 | 254 | 40.8% | 18.5% |
| Incorrect, inadequate or imprecise result or readings | 102 | 16.4% | 10.9% |
| Over-sensing | 89 | 14.3% | 10.4% |
| Pacing problem | 70 | 11.2% | 9% |
| Signal artifact/noise | 70 | 11.2% | 4.1% |
| High impedance | 64 | 10.3% | 6.2% |
| Failure to capture | 41 | 6.6% | 4.2% |
| Battery problema problem with the battery | 36 | 5.8% | 2.1% |
| High capture threshold | 36 | 5.8% | 1.5% |
| Interrogation problem | 22 | 3.5% | 2.7% |
| Under-sensing | 22 | 3.5% | 1.6% |
| Low impedance | 17 | 2.7% | 1.7% |
| Failure to read input signal | 16 | 2.6% | 0.7% |
| Data problem | 15 | 2.4% | 1.6% |
| Connection problema connection problem | 7 | 1.1% | 0.9% |
| Defective devicethe device was defective | 7 | 1.1% | 2.3% |
| Off-label use | 7 | 1.1% | 0.6% |
| Device sensing problem | 6 | 1% | 1.3% |
| Device displays incorrect message | 5 | 0.8% | 0.8% |
| Telemetry discrepancy | 5 | 0.8% | 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 |
|---|---|---|
| Syncope/fainting | 24 | 3.9% |
| Asystole | 17 | 2.7% |
| Device overstimulation of tissue | 12 | 1.9% |
| Discomfortdiscomfort | 8 | 1.3% |
| Pocket erosion | 8 | 1.3% |
| Sepsisa severe body-wide response to infection | 8 | 1.3% |
| Bradycardiaslow heart rate | 7 | 1.1% |
| Dizzinesslight-headedness or unsteadiness | 7 | 1.1% |
| Hematomaa collection of blood under the skin or in tissue | 6 | 1% |
| Loss of consciousnesspassing out | 6 | 1% |
| Anxietyanxiety | 4 | 0.6% |
| Arrhythmia | 4 | 0.6% |
| No patient involvement | 4 | 0.6% |
| Presyncope | 4 | 0.6% |
| Malaisegeneral feeling of being unwell | 3 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Visionist Crt-P | Product code NKE | All MAUDE reports |
|---|---|---|---|
| Reports | 623 | 14,671 | 26,136,888 |
| Share of that pool | — | 4.2% | 0% |
| Classified as death, per 1,000 reports | 6 | 19 | 9 |
| Classified as injury | 46.7% | 54.1% | 36.2% |
| Classified as malfunction | 52.6% | 43.9% | 62.3% |
| Filed by the manufacturer | 99.8% | 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% |
| Visionist X4 Crt-P | 1,778 | 877 | 0.2% |
| 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% |
| 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 Crt-P reports
How many FDA reports name Visionist Crt-P?
623 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 278 in the latest 12 months.
What kinds of events are reported?
malfunction (52.6%), injury (46.7%) and death (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
premature discharge of battery (40.8%), incorrect, inadequate or imprecise result or readings (16.4%), over-sensing (14.3%), pacing problem (11.2%) and signal artifact/noise (11.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.8%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Visionist 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.