FDA Adverse Event
Injury
Summary report: N
HIRES 90K
MDR report key: 2151638
·
Received June 30, 2011
Report
- Report Number
- 3006556115-2011-00326
- Event Type
- Injury
- Date Received
- June 30, 2011
- Date of Event
- June 13, 2011
- Report Date
- June 13, 2011
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Description of Event or Problem · 1
THE PATIENT'S INTERNAL DEVICE REPORTEDLY MIGRATED. THE PATIENT UNDERWENT SURGERY TO REPOSITION THE INTERNAL DEVICE ON (B)(6) 2011. THE PATIENT CONTINUES TO BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HIRES 90K | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS LLC | CI-1400-01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | Required Intervention |