FDA Adverse Event
Injury
Summary report: N
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
MDR report key: 2010916
·
Received March 4, 2011
Report
- Report Number
- 9710014-2011-00075
- Event Type
- Injury
- Date Received
- March 4, 2011
- Date of Event
- February 20, 2011
- Report Date
- March 1, 2011
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN EXPLANTED AND HAS BEEN RETURNED TO INNSBRUCK WHERE IT WILL BE EVALUATED. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ELECTRODE ARRAY WAS EXPOSED IN THE MIDDLE EAR BECAUSE OF MIDDLE EAR INFECTION, SO IT WAS CONTAMINATED. TESTING RESULTS WERE TOTALLY NORMAL. THE PATIENT WAS REIMPLANTED ON (B)(6), 2011.
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 | SONATA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | Required Intervention |