FDA Adverse Event
Injury
Summary report: N
CLARION
MDR report key: 1032794
·
Received April 23, 2008
Report
- Report Number
- 3006556115-2008-00202
- Event Type
- Injury
- Date Received
- April 23, 2008
- Date of Event
- March 25, 2008
- Report Date
- March 25, 2008
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PT ELECTED TO HAVE SURGERY TO REMOVE HIS IMPLANT FOR A TECHNOLOGY UPGRADE. THE PT WAS EXPLANTED AND REIMPLANTED WITH ANOTHER ADVANCED BIONICS DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLARION | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS LLC | AB-5100H | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |