FDA Adverse Event
Malfunction
Summary report: N
CONCERTO
MDR report key: 20332035
·
Received September 30, 2024
Report
- Report Number
- 9710014-2024-00878
- Event Type
- Malfunction
- Date Received
- September 30, 2024
- Date of Event
- September 24, 2024
- Report Date
- December 15, 2025
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
- Product Code
- MCM
- UDI-DI
- 09008737083632
- PMA / PMN Number
- P000025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT SHOULD BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION: BASED ON THE RECEIVED INFORMATION, A DAMAGE TO THE ACTIVE ELECTRODE DUE TO EXCESSIVE MECHANICAL STRESS APPEARS VERY LIKELY. HOWEVER, TO DETERMINE AN EXACT ROOT CAUSE DEVICE INVESTIGATION WOULD BE NECESSARY. RE-IMPLANTATION IS CONSIDERED BUT NO DATE HAS BEEN SCHEDULED YET.
Description of Event or Problem · 0
THE USER'S HEARING PERFORMANCE IS AFFECTED. RE-IMPLANTATION IS CONSIDERED.
Description of Event or Problem · 0
THE USER'S HEARING PERFORMANCE IS AFFECTED. RE-IMPLANTATION IS CONSIDERED, BUT NO DATE HAS BEEN SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 963384 | CONCERTO | COCHLEAR IMPLANT | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH | MI1000 MED-EL CONCERT | 09008737083632 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 YR | Male | Required Intervention |