FDA Adverse Event
Injury
Summary report: N
CLARION
MDR report key: 2070200
·
Received April 20, 2011
Report
- Report Number
- 3006556115-2011-00170
- Event Type
- Injury
- Date Received
- April 20, 2011
- Date of Event
- April 7, 2011
- Report Date
- April 1, 2011
- Manufacturer
- ADVANCED BIONICS, LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE COMPANY WAS INFORMED THAT THE PT'S ELECTRODE HAS REPORTEDLY EXTRUDED. THE PT'S DEVICE WAS EXPLANTED AND THE PT WAS REIMPLANTED WITH ANOTHER COCHLEAR IMPLANT. PARTIAL ELECTRODE ARRAY OF EXPLANTED DEVICE WAS RETURNED TO ADVANCED BIONICS ON (B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLARION | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS, LLC | AB-5100L | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Required Intervention |