Device brand name · Cochlear implant
HiRes Ultra 3D Implant: medical device reports filed with FDA
4,177 reports name it, 2019–2026. Manufacturer given most often on reports: Advanced Bionics. Product code MCM.
- 4,177
- device reports naming the brand
- 0% of all MAUDE reports · about 557 a year
- 532
- reports, 12 months to August 2026
- 736 in the 12 months before
- 58.3%
- classified as malfunction
- 43.1% across the product code
- 0.1%
- classified as death, as reported
- 3 reports · not verified by FDA
FDA's MAUDE database holds 4,177 reports that name the brand "HiRes Ultra 3D Implant" (cochlear implant), received between January 2019 and August 2026; the manufacturer given most often on reports is Advanced Bionics. Spellings of one product vary from report to report.
532 reports arrived in the 12 months to August 2026, down 28% from 736 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 malfunction (58.3%), injury (41.7%) and death (0.1%); 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 mechanical problem (53.5%), impedance problem (18.3%) and migration (10.3%). The patient problems coded most often are appropriate clinical signs, symptoms and conditions term/code not available, failure of implant 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 |
|---|---|---|---|
| Mechanical problema mechanical problem | 2,236 | 53.5% | 9.6% |
| Impedance problem | 766 | 18.3% | 7.6% |
| Migrationthe device moved from where it was placed | 430 | 10.3% | 3.4% |
| Expulsion | 165 | 4% | 3.6% |
| Therapeutic or diagnostic output failure | 164 | 3.9% | 2.2% |
| Insufficient device problem information | 161 | 3.9% | 6% |
| Output problem | 154 | 3.7% | 6.9% |
| Migration or expulsion of device | 113 | 2.7% | 2.3% |
| Material protrusion/extrusion | 52 | 1.2% | 0.4% |
| Output below specifications | 50 | 1.2% | 0.3% |
| Malposition of device | 33 | 0.8% | 0.7% |
| Patient device interaction problem | 25 | 0.6% | 0.3% |
| Loose or intermittent connection | 24 | 0.6% | 0.4% |
| Patient-device incompatibilitythe device did not suit the patient | 22 | 0.5% | 0.3% |
| Intermittent communication failure | 17 | 0.4% | 0.6% |
| Lack of effect | 16 | 0.4% | 0.1% |
| Positioning problem | 16 | 0.4% | 0.3% |
| Difficult to insertthe device was hard to insert | 14 | 0.3% | 0.1% |
| Electrical /electronic property probleman electrical or electronic problem | 8 | 0.2% | 0.3% |
| Unexpected therapeutic results | 7 | 0.2% | 0.7% |
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 | 2,730 | 65.4% |
| Failure of implant | 603 | 14.4% |
| Painpain, site not specified | 182 | 4.4% |
| Therapeutic response, decreased | 123 | 2.9% |
| Dizzinesslight-headedness or unsteadiness | 98 | 2.3% |
| Swelling/ edema | 69 | 1.7% |
| Undesired nerve stimulation | 50 | 1.2% |
| Inflammationinflammation | 43 | 1% |
| Headachehead pain | 42 | 1% |
| Head injurya head injury | 41 | 1% |
| Skin infection | 41 | 1% |
| Tinnitusringing in the ears | 41 | 1% |
| Cerebrospinal fluid leakage | 39 | 0.9% |
| Vertigoa spinning sensation | 39 | 0.9% |
| Skin inflammation/ irritation | 35 | 0.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | HiRes Ultra 3D Implant | Product code MCM | All MAUDE reports |
|---|---|---|---|
| Reports | 4,177 | 75,481 | 26,136,888 |
| Share of that pool | — | 5.5% | 0% |
| Classified as death, per 1,000 reports | 1 | 1 | 9 |
| Classified as injury | 41.7% | 56.2% | 36.2% |
| Classified as malfunction | 58.3% | 43.1% | 62.3% |
| Filed by the manufacturer | 100% | 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 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% |
| Synchrony | 1,298 | 490 | 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 HiRes Ultra 3D Implant reports
How many FDA reports name HiRes Ultra 3D Implant?
4,177 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 532 in the latest 12 months.
What kinds of events are reported?
malfunction (58.3%), injury (41.7%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
mechanical problem (53.5%), impedance problem (18.3%), migration (10.3%), expulsion (4%) and therapeutic or diagnostic output failure (3.9%). 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 HiRes Ultra 3D Implant 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.