FDA Adverse Event
Malfunction
Summary report: N
HIRES 90K IMPLANT
MDR report key: 3894617
·
Received May 21, 2014
Report
- Report Number
- 3006556115-2014-00242
- Event Type
- Malfunction
- Date Received
- May 21, 2014
- Date of Event
- May 1, 2014
- Report Date
- May 1, 2014
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Description of Event or Problem · 1
THE PATIENT REPORTEDLY EXPERIENCED LOSS OF SOUND. EXTERNAL EQUIPMENT WAS EXCHANGED; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. TESTING CONFIRMED THAT THE DEVICE IS NOT FUNCTIONING. DEVICE REVISION SURGERY IS BEING CONSIDERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303943 | HIRES 90K IMPLANT | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS LLC | C1-1400-01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |