FDA Adverse Event
Injury
Summary report: N
HIRES 90K
MDR report key: 683832
·
Received March 6, 2006
Report
- Report Number
- 2029203-2006-00108
- Event Type
- Injury
- Date Received
- March 6, 2006
- Date of Event
- November 17, 2005
- Manufacturer
- ADVANCED BIONICS CORP.
- Product Code
- MCM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
THE PATIENT HAD AN INFECTION AND PAIN AT THE IMPLANT SITE. THE PATIENT WAS TREATED WITH ANTIBIOTICS (TYPE UNKNOWN). HOWEVER, THE INFECTION DID NOT RESOLVE. ON NOVEMBER 17, 2005 THE PATIENT'S DEVICE WAS REPOSITIONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HIRES 90K | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS CORP. | CI-1400-01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Required Intervention |