Devices › Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Device brand name · Implantable cardioverter defibrillator
Unify Assura CRT-D RF HV: medical device reports filed with FDA
6,731 reports name it, 2015–2026. Manufacturer given most often on reports: St Jude Medical Crm-Sylmar. Product code NIK.
- 6,731
- device reports naming the brand
- 0% of all MAUDE reports · about 603 a year
- 186
- reports, 12 months to August 2026
- 281 in the 12 months before
- 51.2%
- classified as malfunction
- 47.2% across the product code
- 3.7%
- classified as death, as reported
- 250 reports · not verified by FDA
FDA's MAUDE database holds 6,731 reports that name the brand "Unify Assura CRT-D RF HV" (implantable cardioverter defibrillator), received between May 2015 and August 2026; the manufacturer given most often on reports is St Jude Medical Crm-Sylmar. Spellings of one product vary from report to report.
186 reports arrived in the 12 months to August 2026, down 34% from 281 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 (51.2%), injury (45.1%) and death (3.7%); across all defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) reports (product code NIK) death is recorded in 2.8% and malfunction in 47.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are over-sensing (40%), inappropriate or unexpected reset (5.4%) and inappropriate/inadequate shock/stimulation (3.6%). The patient problems coded most often are death, pocket erosion and discomfort. 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 170,404 reports carrying product code NIK. 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 |
|---|---|---|---|
| Over-sensing | 2,695 | 40% | 22.3% |
| Inappropriate or unexpected reset | 361 | 5.4% | 2.4% |
| Inappropriate/inadequate shock/stimulation | 242 | 3.6% | 5.2% |
| Battery problema problem with the battery | 205 | 3% | 1.8% |
| Under-sensing | 168 | 2.5% | 1.6% |
| Premature discharge of battery | 164 | 2.4% | 11% |
| Failure to capture | 114 | 1.7% | 4.1% |
| Pacing problem | 114 | 1.7% | 4.9% |
| Signal artifact/noise | 113 | 1.7% | 1.9% |
| Incorrect interpretation of signal | 84 | 1.2% | 0.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 83 | 1.2% | 1.5% |
| High impedance | 82 | 1.2% | 5.6% |
| Failure to interrogate | 77 | 1.1% | 2.3% |
| Failure to deliver shock/stimulation | 49 | 0.7% | 0.6% |
| Communication or transmission problemthe device could not communicate or transmit | 47 | 0.7% | 0.5% |
| Connection problema connection problem | 37 | 0.5% | 0.9% |
| Low impedance | 30 | 0.4% | 1% |
| Data problem | 29 | 0.4% | 0.5% |
| Failure to convert rhythm | 27 | 0.4% | 0.5% |
| Loose or intermittent connection | 27 | 0.4% | 0.6% |
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 | 222 | 3.3% |
| Pocket erosion | 115 | 1.7% |
| Discomfortdiscomfort | 84 | 1.2% |
| Arrhythmia | 81 | 1.2% |
| Therapeutic effects, unexpected | 80 | 1.2% |
| Shock from patient lead(s) | 47 | 0.7% |
| Dizzinesslight-headedness or unsteadiness | 39 | 0.6% |
| Syncopefainting | 36 | 0.5% |
| Fatiguetiredness | 33 | 0.5% |
| Dyspneashortness of breath | 31 | 0.5% |
| Ventricular tachycardiaa fast rhythm from the lower heart chambers | 28 | 0.4% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 27 | 0.4% |
| Hematomaa collection of blood under the skin or in tissue | 26 | 0.4% |
| Complaint, ill-defined | 24 | 0.4% |
| Erosion | 23 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Unify Assura CRT-D RF HV | Product code NIK | All MAUDE reports |
|---|---|---|---|
| Reports | 6,731 | 170,404 | 26,136,888 |
| Share of that pool | — | 4% | 0% |
| Classified as death, per 1,000 reports | 37 | 28 | 9 |
| Classified as injury | 45.1% | 49.8% | 36.2% |
| Classified as malfunction | 51.2% | 47.2% | 62.3% |
| Filed by the manufacturer | 100% | 99.2% | 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 NIK
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Quadra Assura MP ICD | 14,897 | 507 | 2.1% |
| Gallant HF | 8,971 | 1,918 | 0.7% |
| Quadra Assura Crt-D Quad Rf Hv | 7,971 | 14 | 2.5% |
| Quartet | 14,149 | 848 | 5.2% |
| Unify Crt-D | 5,907 | 10 | 3.4% |
| Consulta Crt-D | 4,623 | 0 | 5.9% |
| Unify Assura ICD | 4,511 | 127 | 1.6% |
| Claria MRI Quad CRT-D SureScan | 3,775 | 274 | 2.2% |
| Cognis | 8,694 | 6 | 1.5% |
| Protecta Xt Crt-D | 3,541 | 3 | 4.5% |
| Quadra Assura Ddqp+ | 3,349 | 0 | 2.3% |
| Contak Renewal | 3,745 | 0 | 4.8% |
| Cobalt XT HF Quad CRT-D MRI SureScan | 2,581 | 791 | 3% |
| Quadra Assura ICD | 2,526 | 67 | 0.8% |
| Vigilant X4 Crt-D | 2,275 | 482 | 0.9% |
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 Unify Assura CRT-D RF HV reports
How many FDA reports name Unify Assura CRT-D RF HV?
6,731 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 186 in the latest 12 months.
What kinds of events are reported?
malfunction (51.2%), injury (45.1%) and death (3.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
over-sensing (40%), inappropriate or unexpected reset (5.4%), inappropriate/inadequate shock/stimulation (3.6%), battery problem (3%) and under-sensing (2.5%). 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 Unify Assura CRT-D RF HV 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.