Devices › Pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)
Device brand name · Implantable pacemaker pulse generator
Anthem Rf Crt-P: medical device reports filed with FDA
300 reports name it, 2015–2023. Manufacturer given most often on reports: St Jude Medical Crm-Sylmar. Product code NKE.
- 300
- device reports naming the brand
- 0% of all MAUDE reports · about 27 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 57.3%
- classified as malfunction
- 43.9% across the product code
- 7.3%
- classified as death, as reported
- 22 reports · not verified by FDA
300 medical device reports received by FDA name the brand "Anthem Rf Crt-P" (implantable pacemaker pulse generator); the manufacturer given most often on reports is St Jude Medical Crm-Sylmar; received from April 2015 to December 2023. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (57.3%), injury (35.3%) and death (7.3%); 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 pacemaker found in back-up mode (19.7%), device operates differently than expected (14%) and over-sensing (13.7%). The patient problems coded most often are death, muscle stimulation and dizziness. 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 |
|---|---|---|---|
| Pacemaker found in back-up mode | 59 | 19.7% | 2% |
| Device operates differently than expectedthe device behaved unexpectedly | 42 | 14% | 1.7% |
| Over-sensing | 41 | 13.7% | 10.4% |
| Premature discharge of battery | 24 | 8% | 18.5% |
| Operating system version or upgrade problem | 15 | 5% | 0.2% |
| Failure to interrogate | 13 | 4.3% | 1.3% |
| Data problem | 9 | 3% | 1.6% |
| Signal artifact/noise | 9 | 3% | 4.1% |
| Failure to capture | 7 | 2.3% | 4.2% |
| Incorrect measurementthe device measured wrongly | 5 | 1.7% | 0.8% |
| Premature elective replacement indicator | 5 | 1.7% | 0.5% |
| Capturing problem | 4 | 1.3% | 0.8% |
| No device output | 4 | 1.3% | 0.2% |
| No pacing | 4 | 1.3% | 0.3% |
| Device sensing problem | 3 | 1% | 1.3% |
| Programming issue | 3 | 1% | 0% |
| Telemetry discrepancy | 3 | 1% | 1% |
| Under-sensing | 3 | 1% | 1.6% |
| Application program version or upgrade problem | 2 | 0.7% | 0% |
| High capture threshold | 2 | 0.7% | 1.5% |
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 |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 22 | 7.3% |
| Muscle stimulation | 11 | 3.7% |
| Dizzinesslight-headedness or unsteadiness | 8 | 2.7% |
| Dyspneashortness of breath | 4 | 1.3% |
| Syncopefainting | 4 | 1.3% |
| Arrhythmia | 3 | 1% |
| Discomfortdiscomfort | 3 | 1% |
| Pocket erosion | 3 | 1% |
| Ventricular tachycardiaa fast rhythm from the lower heart chambers | 3 | 1% |
| Bradycardiaslow heart rate | 2 | 0.7% |
| Complaint, ill-defined | 2 | 0.7% |
| Fatiguetiredness | 2 | 0.7% |
| Loss of consciousnesspassing out | 2 | 0.7% |
| Painpain, site not specified | 2 | 0.7% |
| Palpitationsawareness of the heartbeat | 2 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Anthem Rf Crt-P | Product code NKE | All MAUDE reports |
|---|---|---|---|
| Reports | 300 | 14,671 | 26,136,888 |
| Share of that pool | — | 2% | 0% |
| Classified as death, per 1,000 reports | 73 | 19 | 9 |
| Classified as injury | 35.3% | 54.1% | 36.2% |
| Classified as malfunction | 57.3% | 43.9% | 62.3% |
| Filed by the manufacturer | 100% | 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% |
| 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% |
| 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 Anthem Rf Crt-P reports
How many FDA reports name Anthem Rf Crt-P?
300 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 (57.3%), injury (35.3%) and death (7.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
pacemaker found in back-up mode (19.7%), device operates differently than expected (14%), over-sensing (13.7%), premature discharge of battery (8%) and operating system version or upgrade problem (5%). 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 Anthem Rf 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.