Devices › Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Device brand name · Implantable cardioverter defibrillator
Unify Assura ICD: medical device reports filed with FDA
4,511 reports name it, 2015–2026. Manufacturer given most often on reports: St Jude Medical. Product code NIK.
- 4,511
- device reports naming the brand
- 0% of all MAUDE reports · about 401 a year
- 127
- reports, 12 months to August 2026
- 169 in the 12 months before
- 47%
- classified as malfunction
- 47.2% across the product code
- 1.6%
- classified as death, as reported
- 72 reports · not verified by FDA
FDA's MAUDE database holds 4,511 reports that name the brand "Unify Assura ICD" (implantable cardioverter defibrillator), received between April 2015 and August 2026; the manufacturer given most often on reports is St Jude Medical. Spellings of one product vary from report to report.
127 reports arrived in the 12 months to August 2026, down 25% from 169 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 (51.3%), malfunction (47%) and death (1.6%); 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 (35.3%), inappropriate or unexpected reset (6.4%) and battery problem (4.3%). The patient problems coded most often are death, arrhythmia and therapeutic effects, unexpected. 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 | 1,592 | 35.3% | 22.3% |
| Inappropriate or unexpected reset | 287 | 6.4% | 2.4% |
| Battery problema problem with the battery | 192 | 4.3% | 1.8% |
| Premature discharge of battery | 190 | 4.2% | 11% |
| Inappropriate/inadequate shock/stimulation | 129 | 2.9% | 5.2% |
| Pacing problem | 81 | 1.8% | 4.9% |
| Signal artifact/noise | 79 | 1.8% | 1.9% |
| Failure to interrogate | 74 | 1.6% | 2.3% |
| Under-sensing | 74 | 1.6% | 1.6% |
| High impedance | 55 | 1.2% | 5.6% |
| No pacing | 52 | 1.2% | 0.2% |
| Environmental compatibility problem | 51 | 1.1% | 0.4% |
| Failure to capture | 50 | 1.1% | 4.1% |
| Incorrect interpretation of signal | 46 | 1% | 0.7% |
| Pacing asynchronously | 44 | 1% | 0.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 41 | 0.9% | 1.5% |
| Failure to convert rhythm | 25 | 0.6% | 0.5% |
| Communication or transmission problemthe device could not communicate or transmit | 24 | 0.5% | 0.5% |
| Connection problema connection problem | 22 | 0.5% | 0.9% |
| Incorrect measurementthe device measured wrongly | 22 | 0.5% | 0.8% |
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 | 64 | 1.4% |
| Arrhythmia | 57 | 1.3% |
| Therapeutic effects, unexpected | 32 | 0.7% |
| Pocket erosion | 26 | 0.6% |
| Shock from patient lead(s) | 25 | 0.6% |
| Discomfortdiscomfort | 22 | 0.5% |
| Syncopefainting | 19 | 0.4% |
| Dizzinesslight-headedness or unsteadiness | 17 | 0.4% |
| Device overstimulation of tissue | 12 | 0.3% |
| Ventricular tachycardiaa fast rhythm from the lower heart chambers | 11 | 0.2% |
| Syncope/fainting | 10 | 0.2% |
| Hematomaa collection of blood under the skin or in tissue | 8 | 0.2% |
| Cardiac arrestthe heart stopped | 7 | 0.2% |
| Erosion | 7 | 0.2% |
| No patient involvement | 7 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Unify Assura ICD | Product code NIK | All MAUDE reports |
|---|---|---|---|
| Reports | 4,511 | 170,404 | 26,136,888 |
| Share of that pool | — | 2.6% | 0% |
| Classified as death, per 1,000 reports | 16 | 28 | 9 |
| Classified as injury | 51.3% | 49.8% | 36.2% |
| Classified as malfunction | 47% | 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 Assura CRT-D RF HV | 6,731 | 186 | 3.7% |
| Unify Crt-D | 5,907 | 10 | 3.4% |
| Consulta Crt-D | 4,623 | 0 | 5.9% |
| 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 ICD reports
How many FDA reports name Unify Assura ICD?
4,511 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 127 in the latest 12 months.
What kinds of events are reported?
injury (51.3%), malfunction (47%) and death (1.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
over-sensing (35.3%), inappropriate or unexpected reset (6.4%), battery problem (4.3%), premature discharge of battery (4.2%) and inappropriate/inadequate shock/stimulation (2.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Unify Assura ICD 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.