FDA Adverse Event
Malfunction
Summary report: N
CLARION IMPLANT
MDR report key: 3862935
·
Received February 20, 2014
Report
- Report Number
- 3006556115-2014-00058
- Event Type
- Malfunction
- Date Received
- February 20, 2014
- Date of Event
- February 2, 2014
- Report Date
- February 2, 2014
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PT REPORTEDLY HAS NO LOCK BETWEEN THE EXTERNAL EQUIPMENT AND INTERNAL COCHLEAR DEVICE. EXTERNAL EQUIPMENT WAS EXCHANGED, HOWEVER THIS DID NOT RESOLVE THE ISSUE. THE PT'S DEVICE WAS EXPLANTED. THE PT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 106727 | CLARION IMPLANT | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS LLC | AB-5100L | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR |