FDA Adverse Event
Other
Summary report: N
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
MDR report key: 3240780
·
Received July 16, 2013
Report
- Report Number
- 9710014-2013-00289
- Event Type
- Other
- Date Received
- July 16, 2013
- Date of Event
- July 5, 2013
- Report Date
- July 12, 2013
- 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 TO 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 PT UPON ACTIVATION OF THE NEW DEVICE HAD LITTLE TO NO HEARING SENSATION. DIAGNOSTIC IMAGES SHOWS THAT THE ACTIVE ELECTRODE ARRAY WAS PLACED IN THE SEMICIRCULAR CANALS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 330216 | MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM | SONATA +STANDARD | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |