Devices › Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
Device brand name · Defibrillator automatic implantable cardioverter with cardiac resynchronizatio
Cobalt HF CRT-D MRI SureScan: medical device reports filed with FDA
399 reports name it, 2020–2026. Manufacturer given most often on reports: Medtronic Europe Sarl. Product code NIK.
- 399
- device reports naming the brand
- 0% of all MAUDE reports · about 68 a year
- 57
- reports, 12 months to August 2026
- 85 in the 12 months before
- 30.8%
- classified as malfunction
- 47.2% across the product code
- 2.3%
- classified as death, as reported
- 9 reports · not verified by FDA
399 medical device reports received by FDA name the brand "Cobalt HF CRT-D MRI SureScan" (defibrillator automatic implantable cardioverter with cardiac resynchronizatio); the manufacturer given most often on reports is Medtronic Europe Sarl; received from August 2020 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
57 reports arrived in the 12 months to August 2026, down 33% from 85 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 (66.9%), malfunction (30.8%) and death (2.3%); 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 device sensing problem (12.3%), inappropriate/inadequate shock/stimulation (10.3%) and pacing problem (9.8%). The patient problems coded most often are shock from patient lead(s), 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 |
|---|---|---|---|
| Device sensing problem | 49 | 12.3% | 2.6% |
| Inappropriate/inadequate shock/stimulation | 41 | 10.3% | 5.2% |
| Pacing problem | 39 | 9.8% | 4.9% |
| Mechanical problema mechanical problem | 32 | 8% | 1.4% |
| Premature discharge of battery | 29 | 7.3% | 11% |
| Unable to obtain readings | 25 | 6.3% | 0.3% |
| Electromagnetic interference | 21 | 5.3% | 0.7% |
| Missing test results | 20 | 5% | 0.1% |
| Signal artifact/noise | 20 | 5% | 1.9% |
| Inappropriate or unexpected reset | 18 | 4.5% | 2.4% |
| Over-sensing | 16 | 4% | 22.3% |
| Failure to deliver shock/stimulation | 14 | 3.5% | 0.6% |
| Reset problem | 14 | 3.5% | 0.4% |
| Defibrillation/stimulation problem | 12 | 3% | 0.7% |
| High impedance | 9 | 2.3% | 5.6% |
| Electrical /electronic property probleman electrical or electronic problem | 6 | 1.5% | 1.3% |
| Communication or transmission problemthe device could not communicate or transmit | 4 | 1% | 0.5% |
| Migration or expulsion of device | 4 | 1% | 0.4% |
| Capturing problem | 3 | 0.8% | 1% |
| Damaged thread | 3 | 0.8% | 0% |
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 |
|---|---|---|
| Shock from patient lead(s) | 42 | 10.5% |
| Erosion | 17 | 4.3% |
| Discomfortdiscomfort | 13 | 3.3% |
| Tachycardiafast heart rate | 13 | 3.3% |
| Painpain, site not specified | 12 | 3% |
| Erythemaskin redness | 11 | 2.8% |
| Swelling/ edema | 10 | 2.5% |
| Bacteremia | 9 | 2.3% |
| Hematomaa collection of blood under the skin or in tissue | 9 | 2.3% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 9 | 2.3% |
| Medical device site infectioninfection at the device site | 8 | 2% |
| Pocket erosion | 8 | 2% |
| Bacterial infectiona bacterial infection | 7 | 1.8% |
| Wound dehiscencea wound reopened | 7 | 1.8% |
| Dyspneashortness of breath | 6 | 1.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Cobalt HF CRT-D MRI SureScan | Product code NIK | All MAUDE reports |
|---|---|---|---|
| Reports | 399 | 170,404 | 26,136,888 |
| Share of that pool | — | 0.2% | 0% |
| Classified as death, per 1,000 reports | 23 | 28 | 9 |
| Classified as injury | 66.9% | 49.8% | 36.2% |
| Classified as malfunction | 30.8% | 47.2% | 62.3% |
| Filed by the manufacturer | 99.7% | 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 Cobalt HF CRT-D MRI SureScan reports
How many FDA reports name Cobalt HF CRT-D MRI SureScan?
399 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 57 in the latest 12 months.
What kinds of events are reported?
injury (66.9%), malfunction (30.8%) and death (2.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device sensing problem (12.3%), inappropriate/inadequate shock/stimulation (10.3%), pacing problem (9.8%), mechanical problem (8%) and premature discharge of battery (7.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%) and voluntary reports (0.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Cobalt HF CRT-D MRI SureScan 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.