FDA Adverse Event
Malfunction
Summary report: N
HIRES 90K
MDR report key: 2091126
·
Received May 9, 2011
Report
- Report Number
- 3006556115-2011-00214
- Event Type
- Malfunction
- Date Received
- May 9, 2011
- Date of Event
- April 13, 2011
- Report Date
- April 18, 2011
- Manufacturer
- ADVANCED BIONICS, LLC.
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PT REPORTEDLY EXPERIENCED PERFORMANCE ISSUES WITH HER INTERNAL DEVICE. THE PT'S DEVICE WAS EXPLANTED. THE PT WAS REIMPLANTED WITH ANOTHER COCHLEAR IMPLANT.
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 | 83 YR |