FDA Adverse Event
Injury
Summary report: N
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
MDR report key: 4840414
·
Received June 11, 2015
Report
- Report Number
- 9710014-2015-00417
- Event Type
- Injury
- Date Received
- June 11, 2015
- Date of Event
- May 3, 2015
- Report Date
- September 17, 2015
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: DAMAGE TO THE ACTIVE ELECTRODE, AS MIGHT BE CAUSED BY AN EXTERNAL MECHANICAL IMPACT, WAS DETERMINED TO BE THE ROOT CAUSE OF DEVICE FAILURE. THE PROBLEMS GIVEN IN THE PATIENT REPORT APPEAR TO MATCH THE DAMAGE FOUND. THIS IS A FINAL REPORT.
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MFR FOR EVAL. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S ACCESS TO SOUND WITH THE DEVICE WAS AFFECTED WHILST PLAYING IN THE GARDEN. THE PT WILL BE RE-IMPLANTED ON (B)(6) 2015.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT LOST ACCESS TO SOUND WITH THE DEVICE WHILST PLAYING IN THE GARDEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 381443 | MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM | COCHLEAR IMPLANT | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH | MI1000 MED-EL CONCERT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Required Intervention |