SONATA
Report
- Report Number
- 9710014-2025-00952
- Event Type
- Malfunction
- Date Received
- October 15, 2025
- Date of Event
- August 10, 2025
- Report Date
- November 21, 2025
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
- Product Code
- MCM
- UDI-DI
- 09008737049119
- PMA / PMN Number
- P000025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- 003
Narratives
ADDITIONAL INFORMATION: BASED ON THE RECEIVED INFORMATION, A DAMAGE TO THE ACTIVE ELECTRODE DUE TO EXCESSIVE MECHANICAL STRESS SEEMS 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.
ADDITIONAL INFORMATION: BASED ON THE RECEIVED INFORMATION, A DAMAGE TO THE ACTIVE ELECTRODE DUE TO EXCESSIVE MECHANICAL STRESS SEEMS 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. CORRECTION: G07003; G02015. B14 WAS DELETED. C070602; C070604.
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.
THE USER DOES NOT RESPOND TO SOUND WITH THE DEVICE FOR THE LAST TWO MONTHS. THE USER WILL BE RE-IMPLANTED.
THE USER DOES NOT RESPOND TO SOUND WITH THE DEVICE FOR THE LAST TWO MONTHS. THE USER WILL BE RE-IMPLANTED.
THE USER DOES NOT RESPOND TO SOUND WITH THE DEVICE FOR THE LAST 2 MONTHS. THE USER WILL BE RE-IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2004313 | SONATA | COCHLEAR IMPLANT | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH | SONATA | 09008737049119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR | Male |