FDA Adverse Event
Malfunction
Summary report: N
HIRES 90K IMPLANT
MDR report key: 3061573
·
Received April 11, 2013
Report
- Report Number
- 3006556115-2013-00145
- Event Type
- Malfunction
- Date Received
- April 11, 2013
- Date of Event
- April 3, 2013
- Report Date
- March 22, 2013
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Description of Event or Problem · 1
THE PATIENT REPORTEDLY EXPERIENCED LOSS OF SOUND FOLLOWED BY LOSS OF LOCK BETWEEN THE INTERNAL DEVICE AND THE EXTERNAL EQUIPMENT. EXTERNAL EQUIPMENT WAS EXCHANGED; HOWEVER, THE ISSUE WAS NOT RESOLVED. THE PATIENT WAS EXPLANTED AND REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155546 | HIRES 90K IMPLANT | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS LLC | CI-1400-01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR |