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FDA product code NIK · class 3 · Unknown
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d): medical device reports filed with FDA
170,404 reports carry this product code, 2000–2026; 30 brands with a page.
- 170,404
- reports with this product code
- 0.7% of all MAUDE reports
- 10,862
- reports, 12 months to August 2026
- 11,171 in the 12 months before
- 47.2%
- classified as malfunction
- 62.3% across all reports
- 2.8%
- classified as death, as reported
- 0.9% across all reports
Product code NIK is FDA's classification for "Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)" (unknown panel), a class 3 device. 170,404 medical device reports carry this product code, 0.7% of the MAUDE database, from March 2000 to August 2026.
10,862 reports arrived in the 12 months to August 2026, close to the 11,171 of 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 (49.8%), malfunction (47.2%) and death (2.8%). 30 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
| Brand | Reports | Latest 12 months | Classified as death | Classified as malfunction |
|---|---|---|---|---|
| Quadra Assura MP ICD | 13,166 | 507 | 2.1% | 72.1% |
| Gallant HF | 8,969 | 1,918 | 0.7% | 87.3% |
| Quadra Assura Crt-D Quad Rf Hv | 7,970 | 14 | 2.5% | 43.6% |
| Quartet | 7,450 | 848 | 5.2% | 39.9% |
| Unify Assura CRT-D RF HV | 6,727 | 186 | 3.7% | 51.2% |
| Unify Crt-D | 5,903 | 10 | 3.4% | 15.7% |
| Consulta Crt-D | 4,533 | 0 | 5.9% | 12.6% |
| Unify Assura ICD | 4,509 | 127 | 1.6% | 47% |
| Claria MRI Quad CRT-D SureScan | 3,775 | 274 | 2.2% | 38.8% |
| Cognis | 3,678 | 6 | 1.5% | 41% |
| Protecta Xt Crt-D | 3,508 | 3 | 4.5% | 19.7% |
| Quadra Assura Ddqp+ | 3,348 | 0 | 2.3% | 35% |
| Contak Renewal | 2,748 | 0 | 4.8% | 60.4% |
| Cobalt XT HF Quad CRT-D MRI SureScan | 2,581 | 791 | 3% | 30.6% |
| Quadra Assura ICD | 2,524 | 67 | 0.8% | 61.6% |
| Vigilant X4 Crt-D | 2,275 | 482 | 0.9% | 42.4% |
| Viva Xt | 2,130 | 0 | 4.6% | 34.3% |
| Momentum Crt-D | 2,116 | 476 | 0.7% | 48.9% |
| Resonate X4 Crt-D | 2,011 | 454 | 0.9% | 50.9% |
| Easytrak 2 | 1,987 | 18 | 0.8% | 26.6% |
| Quadra Assura Crt-D Df-4 Connector | 1,908 | 0 | 1.4% | 85.1% |
| Claria MRI CRT-D SureScan | 1,680 | 97 | 2% | 44.3% |
| Quartet Lead Small-S, 86 cm | 1,622 | 159 | 2.1% | 46.2% |
| Contak Renewal 3 | 1,549 | 0 | 5.7% | 72.8% |
| Amplia MRI Quad CRT-D SureScan | 1,481 | 81 | 2.2% | 48.4% |
| Viva Quad Xt | 1,438 | 0 | 3.8% | 45.9% |
| Dynagen X4 Crt-D | 1,274 | 172 | 1.2% | 43.2% |
| Viva XT CRT-D | 1,246 | 38 | 1.8% | 32.8% |
| Gallant VR | 1,226 | 245 | 2% | 62.2% |
| Inogen X4 Crt-D | 1,182 | 134 | 0.7% | 42.6% |
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| St Jude Medical Crm-Sylmar | 34,211 | 20.1% |
| St Jude Medical | 15,058 | 8.8% |
| Guidant Crm Clonmel Ireland | 12,872 | 7.6% |
| Boston Scientific | 12,359 | 7.3% |
| St Jude Medical Crm-Sunnyvale | 12,334 | 7.2% |
| Medtronic Europe Sarl | 11,814 | 6.9% |
| Abbott | 9,941 | 5.8% |
| Medtronic Med Rel Medtronic Puerto Rico | 8,808 | 5.2% |
| Medtronic Med Rel | 8,488 | 5% |
| St Jude Medical Crmd | 8,471 | 5% |
| Medtronic Puerto Rico Operations | 4,833 | 2.8% |
| Cardiac Pacemakers | 4,161 | 2.4% |
| St Jude Medical Cardiac Rhythm Management Division | 3,831 | 2.2% |
| Ipg Mfg Switzerland | 3,327 | 2% |
| Biotronik Se & Kg | 2,651 | 1.6% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Over-sensing | 37,926 | 22.3% |
| Premature discharge of battery | 18,684 | 11% |
| High impedance | 9,486 | 5.6% |
| Inappropriate/inadequate shock/stimulation | 8,854 | 5.2% |
| Pacing problem | 8,281 | 4.9% |
| Failure to capture | 6,921 | 4.1% |
| Device sensing problem | 4,439 | 2.6% |
| Inappropriate or unexpected reset | 4,129 | 2.4% |
| Device dislodged or dislocated | 4,115 | 2.4% |
| Low battery | 4,070 | 2.4% |
| Failure to interrogate | 3,980 | 2.3% |
| Signal artifact/noise | 3,238 | 1.9% |
| Battery problema problem with the battery | 3,124 | 1.8% |
| Under-sensing | 2,807 | 1.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 2,544 | 1.5% |
| Mechanical problema mechanical problem | 2,436 | 1.4% |
| Premature elective replacement indicator | 2,434 | 1.4% |
| Electrical /electronic property probleman electrical or electronic problem | 2,297 | 1.3% |
| Insufficient device problem information | 2,289 | 1.3% |
| Capturing problem | 1,737 | 1% |
Questions about defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) reports
What is product code NIK?
FDA's classification code for "Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.
How many reports carry this code?
170,404 reports through August 2026, 10,862 of them in the latest 12 months.
Which brands appear most often?
Quadra Assura MP ICD (13,166), Gallant HF (8,969), Quadra Assura Crt-D Quad Rf Hv (7,970), Quartet (7,450) and Unify Assura CRT-D RF HV (6,727). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.