Devices › Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Device brand name · Implantable chf pulse generator
Cognis He Is-1/Df-1/Is-1: medical device reports filed with FDA
1,054 reports name it, 2008–2010. Manufacturer given most often on reports: Guidant Crm Clonmel Ireland. Product code NIK.
- 1,054
- device reports naming the brand
- 0% of all MAUDE reports · about 59 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 45.9%
- classified as malfunction
- 47.2% across the product code
- 0.1%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 1,054 reports that name the brand "Cognis He Is-1/Df-1/Is-1" (implantable chf pulse generator), received between October 2008 and May 2010; the manufacturer given most often on reports is Guidant Crm Clonmel Ireland. Spellings of one product vary from report to report.
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 injury (53.8%), malfunction (45.9%) and other (0.2%); 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 (19%), high impedance (18.9%) and pacing problem (14.6%). The patient problems coded most often are surgical procedure, repeated, other (for use when an appropriate patient code cannot be identified) and asystole. 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
No report naming Cognis He Is-1/Df-1/Is-1 was received in the five years to August 2026; the latest was received in May 2010.
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 | 200 | 19% | 22.3% |
| High impedance | 199 | 18.9% | 5.6% |
| Pacing problem | 154 | 14.6% | 4.9% |
| Noise | 140 | 13.3% | 0.5% |
| Normal | 105 | 10% | 0.8% |
| Mechanical problema mechanical problem | 94 | 8.9% | 1.4% |
| Connection error | 79 | 7.5% | 0.1% |
| Inappropriate/inadequate shock/stimulation | 62 | 5.9% | 5.2% |
| Failure to capture | 60 | 5.7% | 4.1% |
| Difficult to insertthe device was hard to insert | 50 | 4.7% | 0.2% |
| Under-sensing | 43 | 4.1% | 1.6% |
| Device displays incorrect message | 41 | 3.9% | 0.8% |
| Loose or intermittent connection | 40 | 3.8% | 0.6% |
| Device sensing problem | 32 | 3% | 2.6% |
| Loss of threshold | 28 | 2.7% | 0.2% |
| Malfunction | 28 | 2.7% | 0.4% |
| Connection problema connection problem | 20 | 1.9% | 0.9% |
| Pacing inadequately | 17 | 1.6% | 0.1% |
| Contamination | 14 | 1.3% | 0% |
| Low battery | 14 | 1.3% | 2.4% |
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 |
|---|---|---|
| Surgical procedure, repeated | 59 | 5.6% |
| Other (for use when an appropriate patient code cannot be identified) | 51 | 4.8% |
| Asystole | 23 | 2.2% |
| Surgery, prolonged | 19 | 1.8% |
| Syncopefainting | 19 | 1.8% |
| Atrial fibrillationan irregular heart rhythm | 12 | 1.1% |
| Pocket erosion | 11 | 1% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 9 | 0.9% |
| Deaththe patient died; cause not stated by this term | 6 | 0.6% |
| Hematomaa collection of blood under the skin or in tissue | 4 | 0.4% |
| Ventricular tachycardiaa fast rhythm from the lower heart chambers | 3 | 0.3% |
| Arrhythmia | 2 | 0.2% |
| Atrial flutter | 2 | 0.2% |
| Arteriosclerosis | 1 | 0.1% |
| Congestive heart failure | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Cognis He Is-1/Df-1/Is-1 | Product code NIK | All MAUDE reports |
|---|---|---|---|
| Reports | 1,054 | 170,404 | 26,136,888 |
| Share of that pool | — | 0.6% | 0% |
| Classified as death, per 1,000 reports | 1 | 28 | 9 |
| Classified as injury | 53.8% | 49.8% | 36.2% |
| Classified as malfunction | 45.9% | 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% |
| 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% |
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 Cognis He Is-1/Df-1/Is-1 reports
How many FDA reports name Cognis He Is-1/Df-1/Is-1?
1,054 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?
injury (53.8%), malfunction (45.9%) and other (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
over-sensing (19%), high impedance (18.9%), pacing problem (14.6%), noise (13.3%) and normal (10%). 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 Cognis He Is-1/Df-1/Is-1 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.