FDA Adverse Event
Injury
Summary report: N
HIRES 90K
MDR report key: 2112362
·
Received May 25, 2011
Report
- Report Number
- 3006556115-2011-00253
- Event Type
- Injury
- Date Received
- May 25, 2011
- Date of Event
- April 29, 2011
- Report Date
- May 4, 2011
- Manufacturer
- ADVANCED BIONICS, LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Description of Event or Problem · 1
THE COMPANY WAS INFORMED THAT THE PT WAS EXPLANTED DUE TO THE ELECTRODE ARRAY BEING IN THE MIDDLE EAR SPACE. ADVANCED BIONICS IS IN THE PROCESS OF GETTING MORE INFO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HIRES 90K | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS, LLC | CI-1400-02H | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR | Required Intervention |