Device brand name · Nucleus 24 cochlear implant system
Nucleus CI612 Cochlear Implant with Contour Advance Electrode: medical device reports filed with FDA
1,266 reports name it, 2019–2026. Manufacturer given most often on reports: Cochlear. Product code MCM.
- 1,266
- device reports naming the brand
- 0% of all MAUDE reports · about 185 a year
- 235
- reports, 12 months to August 2026
- 290 in the 12 months before
- 6.2%
- classified as malfunction
- 43.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 1,266 reports that name the brand "Nucleus CI612 Cochlear Implant with Contour Advance Electrode" (nucleus 24 cochlear implant system), received between September 2019 and August 2026; the manufacturer given most often on reports is Cochlear. Spellings of one product vary from report to report.
235 reports arrived in the 12 months to August 2026, down 19% from 290 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 (93.8%) and malfunction (6.2%); across all implant, cochlear reports (product code MCM) death is recorded in 0.1% and malfunction in 43.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are expulsion (12.7%), positioning failure (9.8%) and therapeutic or diagnostic output failure (6.3%). The patient problems coded most often are appropriate clinical signs, symptoms and conditions term/code not available, tissue breakdown and pain. 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 75,481 reports carrying product code MCM. 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 |
|---|---|---|---|
| Expulsion | 161 | 12.7% | 3.6% |
| Positioning failure | 124 | 9.8% | 1% |
| Therapeutic or diagnostic output failure | 80 | 6.3% | 2.2% |
| Migrationthe device moved from where it was placed | 74 | 5.8% | 3.4% |
| Insufficient device problem information | 62 | 4.9% | 6% |
| Circuit failure | 60 | 4.7% | 2.2% |
| Failure to deliver shock/stimulation | 46 | 3.6% | 0.4% |
| Output problem | 39 | 3.1% | 6.9% |
| Electrical shorting | 36 | 2.8% | 0.4% |
| Unexpected therapeutic results | 31 | 2.4% | 0.7% |
| Malposition of device | 22 | 1.7% | 0.7% |
| Failure to read input signal | 18 | 1.4% | 0.3% |
| Patient device interaction problem | 17 | 1.3% | 0.3% |
| No device output | 15 | 1.2% | 5% |
| Inadequacy of device shape and/or size | 14 | 1.1% | 0.2% |
| Patient-device incompatibilitythe device did not suit the patient | 14 | 1.1% | 0.3% |
| Signal artifact/noise | 14 | 1.1% | 0.2% |
| Device appears to trigger rejection | 11 | 0.9% | 0.8% |
| Impedance problem | 8 | 0.6% | 7.6% |
| Loose or intermittent connection | 8 | 0.6% | 0.4% |
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 |
|---|---|---|
| Appropriate clinical signs, symptoms and conditions term/code not available | 424 | 33.5% |
| Tissue breakdown | 130 | 10.3% |
| Painpain, site not specified | 83 | 6.6% |
| Failure of implant | 42 | 3.3% |
| Swelling/ edema | 42 | 3.3% |
| Head injurya head injury | 41 | 3.2% |
| Medical device site infectioninfection at the device site | 39 | 3.1% |
| Wound dehiscencea wound reopened | 39 | 3.1% |
| Bacterial infectiona bacterial infection | 36 | 2.8% |
| Undesired nerve stimulation | 32 | 2.5% |
| Implant pain | 23 | 1.8% |
| Skin infection | 23 | 1.8% |
| Necrosisdeath of tissue | 22 | 1.7% |
| Post operative wound infection | 21 | 1.7% |
| Tinnitusringing in the ears | 19 | 1.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Nucleus CI612 Cochlear Implant with Contour Advance Electrode | Product code MCM | All MAUDE reports |
|---|---|---|---|
| Reports | 1,266 | 75,481 | 26,136,888 |
| Share of that pool | — | 1.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 93.8% | 56.2% | 36.2% |
| Classified as malfunction | 6.2% | 43.1% | 62.3% |
| Filed by the manufacturer | 65.7% | 91.7% | 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 MCM
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Nucleus 24 Channel Cochlear Implant System | 12,137 | 0 | 0.1% |
| Med-El Maestro Cochlear Implant System | 7,391 | 0 | 0% |
| MED-EL Combi 40+ Cochlear Implant System | 6,149 | 0 | 0% |
| HiRes Ultra Implant | 5,384 | 404 | 0% |
| HiRes Ultra 3D Implant | 4,177 | 532 | 0.1% |
| HiRes 90K | 3,452 | 30 | 0.1% |
| HiRes 90K Implant | 2,754 | 89 | 0% |
| Nucleus CI512 Cochlear Implant with Contour Advance Electrode | 2,605 | 232 | 0% |
| Clarion | 2,563 | 0 | 0.8% |
| Nucleus CI622 Cochlear Implant with Slim Straight Electrode | 2,398 | 510 | 0% |
| Nucleus CI632 Profile Plus with Slim Modiolar Electrode | 2,353 | 461 | 0% |
| HiRes 90K Advantage Implant | 2,226 | 86 | 0% |
| Nucleus Freedom Implant with Contour Advance Electrode | 1,973 | 189 | 0.2% |
| CLARION Implant | 1,729 | 169 | 0% |
| Nucleus CI522 Cochlear Implant with Slim Straight Electrode | 1,584 | 179 | 0% |
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 Nucleus CI612 Cochlear Implant with Contour Advance Electrode reports
How many FDA reports name Nucleus CI612 Cochlear Implant with Contour Advance Electrode?
1,266 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 235 in the latest 12 months.
What kinds of events are reported?
injury (93.8%) and malfunction (6.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
expulsion (12.7%), positioning failure (9.8%), therapeutic or diagnostic output failure (6.3%), migration (5.8%) and insufficient device problem information (4.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (65.7%) and distributor reports (34.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Nucleus CI612 Cochlear Implant with Contour Advance Electrode 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.