FDA Adverse Event
Malfunction
Summary report: N
MED-EL MAESTRO COCHLEAR IMPLATN SYSTEM
MDR report key: 3131186
·
Received May 22, 2013
Report
- Report Number
- 9710014-2013-00196
- Event Type
- Malfunction
- Date Received
- May 22, 2013
- Date of Event
- May 8, 2013
- Report Date
- May 17, 2013
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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 DURING INITIAL SWITCH-ON THE PT'S IMPLANT ON (B)(6) 2013, AT THE CLINIC, IT WAS FOUND THAT ALL THE ELECTRODE CHANNELS WERE SHOWING HI IMPEDANCE. FOUR ELECTRODE CHANNELS ALSO SHOWED SHORT CIRCUITS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 227511 | MED-EL MAESTRO COCHLEAR IMPLATN SYSTEM | MED-EL CONCERT +FLEX28 | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |