FDA Adverse Event
Malfunction
Summary report: N
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
MDR report key: 3952579
·
Received May 15, 2014
Report
- Report Number
- 9710014-2014-00240
- Event Type
- Malfunction
- Date Received
- May 15, 2014
- Date of Event
- April 24, 2014
- Report Date
- April 30, 2014
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT SUSTAINED A FALL AND BLOW TO THE HEAD ON THE IMPLANT SIDE ON (B)(6) 2014. THE PATIENT TRIED TO USE THE PROCESSOR IMMEDIATELY AFTER THE FALL; HOWEVER, THERE WAS NO ACCESS TO SOUND. HE WAS ADVISED BY HIS SURGEON TO NOT USE THE AUDIO PROCESSOR UNTIL HE WAS SEEN BY THE AUDIOLOGIST AND SURGEON. THE PATIENT WAS SEEN ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 291224 | MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM | MED-EL CONCERT +FLEX28 | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR |