FDA Adverse Event
Malfunction
Summary report: N
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
MDR report key: 2093059
·
Received April 15, 2011
Report
- Report Number
- 9710014-2011-00121
- Event Type
- Malfunction
- Date Received
- April 15, 2011
- Date of Event
- April 3, 2011
- Report Date
- April 11, 2011
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT REPORTED INTERMITTENCY WITH HER HEARING WITH HER IMPLANT OVER A MONTH AGO. A NEW SPEECH PROCESSOR WAS PROGRAMMED AND SENT TO HER, HOWEVER THIS DID NOT RESOLVE THE PROBLEM. ON SUNDAY, (B)(6) 2011, THE IMPLANT SUDDENLY STOPPED WORKING. SINCE THE EPISODE SHE HAS NOT HEARD ANY SOUND. TESTING CARRIED OUT CONFIRMED THAT THE DEVICE HAS MALFUNCTIONED.
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 | 26 YR |