COMBI C40
Report
- Report Number
- 9710014-2024-00647
- Event Type
- Malfunction
- Date Received
- July 23, 2024
- Date of Event
- July 19, 2024
- Report Date
- January 20, 2025
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- 003
Narratives
CONCLUSION: DEVICE INVESTIGATION CONFIRMED THAT THE STIMULATOR ELECTRONICS IS NOT WORKING ACCORDING TO SPECIFICATIONS. BASED ON THE MANUFACTURER'S EXPERIENCE WITH THIS KIND OF DEVICES, IT CAN BE ASSUMED THAT THE DEVICE HAS FAILED DUE TO LOSS OF HERMETICITY AT THE HOUSING BRAZE JOINT. THE INVESTIGATION RESULTS APPEAR TO MATCH THE PROBLEMS MENTIONED IN THE RECIPIENT REPORT. THIS IS A FINAL REPORT.
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 INFORMATION: ACCORDING TO THE COMPLAINT INFORMATION AND THE MANUFACTURER_S EXPERIENCE WITH THIS KIND OF DEVICE, IT IS ASSUMED THAT THE DEVICE MIGHT HAVE FAILED DUE TO HUMIDITY INGRESS AT THE HOUSING BRAZE JOINT THROUGH MICRO-LEAKS. HOWEVER TO DETERMINE AN EXACT ROOT CAUSE OF FAILURE A DEVICE INVESTIGATION OF THE EXPLANTED DEVICE WOULD BE NECESSARY. FURTHER MEDICAL INTERVENTION IS CONSIDERED BUT NO DATE HAS BEEN SCHEDULED YET.
THE USERS HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER WAS REIMPLANTED.
THE USERS HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED.
THE USERS HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2479286 | COMBI C40 | COCHLEAR IMPLANT | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH | C40+ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Female | Required Intervention |