FDA Adverse Event
Injury
Summary report: N
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
MDR report key: 3213861
·
Received July 3, 2013
Report
- Report Number
- 9710014-2013-00269
- Event Type
- Injury
- Date Received
- July 3, 2013
- Report Date
- June 28, 2013
- 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 MFR 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 CLINIC STATED THAT THE PATIENT HAS NOT MADE EXPECTED PROGRESS WITH HIS LEFT COCHLEAR IMPLANT. PATIENT HAS EXTENSIVE FACIAL NERVE STIMULATION AFFECTING THE ABILITY TO PROGRAM APPROPRIATELY. THE PATIENT HAS SUBSEQUENTLY BEEN EXPLANTED OF THE DEVICE AND RE-IMPLANTED WITH AN IMPLANT WITH A DIFFERENT TYPE OF ELECTRODE ARRAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306512 | MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM | SONATA H MEDIUM | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Required Intervention |