FDA Adverse Event
Malfunction
Summary report: N
HIRES 90K
MDR report key: 1061516
·
Received June 17, 2008
Report
- Report Number
- 3006556115-2008-00323
- Event Type
- Malfunction
- Date Received
- June 17, 2008
- Date of Event
- June 6, 2008
- Report Date
- May 23, 2008
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Description of Event or Problem · 1
THE PATIENT REPORTEDLY EXPERIENCED SOUND QUALITY ISSUES WITH HER INTERNAL DEVICE. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE ATTEMPTED; HOWEVER, THIS DID NOT RESOLVE THE PROBLEM. THE PT'S INTERNAL DEVICE WAS EXPLANTED. THE PT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS DEVICE.
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 | 41 YR |