FDA Adverse Event
Malfunction
Summary report: N
HIRES 90K IMPLANT
MDR report key: 3193149
·
Received June 25, 2013
Report
- Report Number
- 3006556115-2013-00267
- Event Type
- Malfunction
- Date Received
- June 25, 2013
- Date of Event
- June 4, 2013
- Report Date
- June 4, 2013
- Manufacturer
- ADVANCED BIONICS, LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RS
- Reporter Occupation
- AUDIOLOGIST
Narratives
Description of Event or Problem · 1
THE PT REPORTEDLY EXPERIENCED A LOSS OF SOUND AND LOSS OF LOCK. EXTERNAL EQUIPMENT WAS EXCHANGED, HOWEVER, THIS DID NOT RESOLVE THE ISSUE. REVISION SURGERY IS UNDER CONSIDERATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 286897 | HIRES 90K IMPLANT | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS, LLC | CI-1400-01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR |