FDA Adverse Event
Malfunction
Summary report: N
HIRES 90K
MDR report key: 2063813
·
Received April 4, 2011
Report
- Report Number
- 3006556115-2011-00140
- Event Type
- Malfunction
- Date Received
- April 4, 2011
- Date of Event
- March 15, 2011
- Report Date
- March 15, 2011
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PT WAS REPORTEDLY EXPERIENCING INTERMITTENCIES AND LOSS OF LOCK. EXTERNAL EQUIPMENT WAS EXCHANGED, HOWEVER, THIS DID NOT RESOLVE THE ISSUE. TESTING OF THE DEVICE SHOWED ABNORMAL RESULTS. SURGERY TO EXPLANT THIS PT'S DEVICE HAS BEEN SCHEDULED.
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 | 8 YR |