FDA Adverse Event
Malfunction
Summary report: N
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
MDR report key: 4102068
·
Received September 15, 2014
Report
- Report Number
- 9710014-2014-00463
- Event Type
- Malfunction
- Date Received
- September 15, 2014
- Date of Event
- August 6, 2014
- Report Date
- September 3, 2014
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- 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 FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT IN SITU TESTING PERFORMED ON (B)(6) 2014, SHOWED 11 ELECTRODE CHANNELS WITH STATUS HI. PREVIOUS IN SITU TESTING, PERFORMED ON (B)(6) 2014 WAS WITHIN NORMAL LIMITS. REPORTEDLY THE PATIENT IS EXTREMELY ACTIVE AND CONTINUALLY BUMPS HER HEAD. THE PATIENT'S PARENTS COULD NOT DENY TRAUMA TO THE IMPLANT. RE-IMPLANTATION IS BEING CONSIDERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 569163 | MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM | MED-EL CONCERT + FLEX28 | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR |