FDA Adverse Event
Injury
Summary report: N
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
MDR report key: 2180930
·
Received July 22, 2011
Report
- Report Number
- 9710014-2011-00221
- Event Type
- Injury
- Date Received
- July 22, 2011
- Date of Event
- January 1, 2011
- Report Date
- July 19, 2011
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT REPORTED POOR SOUND QUALITY AND SPEECH PERCEPTION, WHICH CORRELATED WITH THE APPEARANCE OF A SHORT CIRCUIT ON ELECTRODES 6 AND 11. THE CLINIC HAD PREVIOUSLY TURNED OFF ELECTRODE 11 BUT LEFT ELECTRODE 6 STILL ACTIVE. ELECTRODE 6 WAS TURNED OFF AND THE PT REPORTED SIGNIFICANT IMPROVEMENT IN SOUND QUALITY. SPEECH PERCEPTION AND PERFORMANCE APPEAR TO BE UNAFFECTED. A CT SCAN CARRIED OUT WAS UNREMARKABLE, WITH ALL ELECTRODES INSERTED INTO THE COCHLEAR. THE EXTERNAL EQUIPMENT WAS CHECKED AND FOUND TO BE WORKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM | COCHLEAR IMPLANT | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH | C40+ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |