FDA Adverse Event
Injury
Summary report: N
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
MDR report key: 2960491
·
Received February 11, 2013
Report
- Report Number
- 9710014-2013-00046
- Event Type
- Injury
- Date Received
- February 11, 2013
- Date of Event
- December 28, 2012
- Report Date
- February 1, 2013
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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 ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A MASTOID SURGERY ON (B)(6) 2012, ON THE RIGHT SIDE DUE TO A MASTOIDITIS. DURING THIS SURGERY, THE ACTIVE ELECTRODE WAS ACCIDENTALLY CUT. THE IMPLANT AND THE ACTIVE ELECTRODE WERE LEFT IN SITU. RE-IMPLANTATION IS PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58346 | MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM | MED-EL CONCERT +STANDARD | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Required Intervention |