FDA Adverse Event
Malfunction
Summary report: N
HIRES 90K ADVANTAGE IMPLANT
MDR report key: 3243042
·
Received July 18, 2013
Report
- Report Number
- 3006556115-2013-00320
- Event Type
- Malfunction
- Date Received
- July 18, 2013
- Date of Event
- June 27, 2013
- Report Date
- June 27, 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
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PT REFUSES TO WEAR THE DEVICE. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE MADE; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. REVISION SURGERY HAS BEEN SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 336414 | HIRES 90K ADVANTAGE IMPLANT | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS LLC | CI-1500-02H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR |