FDA Adverse Event
Injury
Summary report: N
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
MDR report key: 2212458
·
Received August 10, 2011
Report
- Report Number
- 9710014-2011-00222
- Event Type
- Injury
- Date Received
- August 10, 2011
- Date of Event
- January 1, 2011
- Report Date
- August 4, 2011
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN EXPLANTED AND HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS EXPLANTED BY THE CLINIC WITHOUT INFORMING MED-EL ABOUT THE SURGERY BEFORE IT TOOK PLACE. PATIENT NOTES HAD PREVIOUSLY SHOWN THAT THERE WAS FACIAL STIMULATION ON SOME ELECTRODE CHANNELS. THESE CHANNELS HAD BEEN TURNED OFF.
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 | 12 YR | Required Intervention |