FDA Adverse Event
Malfunction
Summary report: N
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
MDR report key: 3013070
·
Received March 15, 2013
Report
- Report Number
- 9710014-2013-00097
- Event Type
- Malfunction
- Date Received
- March 15, 2013
- Date of Event
- March 4, 2013
- Report Date
- March 11, 2013
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- 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 MFR FOR EVAL. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WENT TO THE HOSPITAL FOR A NORMAL REVIEW OF HER FITTING MAPS. DURING THE REVIEW, IT WAS SEEN THAT ALL THE ELECTRODE CHANNELS HAD HI IMPEDANCE STATUS. NO ACCIDENT OR TRAUMA IS KNOWN. PREVIOUSLY, ALL ELECTRODE CHANNELS WERE FUNCTIONAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110695 | MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM | SONATA +STANDARD | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 MO |