FDA Adverse Event
Injury
Summary report: N
HIRES 90K
MDR report key: 1040281
·
Received May 8, 2008
Report
- Report Number
- 3006556115-2008-00219
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- March 12, 2008
- Report Date
- April 11, 2008
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- AUDIOLOGIST
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO ADVANCED BIONICS, THAT THE PT'S DEVICE WAS EXPLANTED DUE TO INFECTION, HOWEVER, THE ELECTRODE ARRAY WAS LEFT IN COCHLEOSTOMY. THE PT REPORTEDLY DEVELOPED AN INFECTION A DAY FOLLOWING THE IMPLANT SURGERY. THE PT WAS RECOMMENDED TO NOT USE THE EXTERNAL EQUIPMENT AT THAT TIME. THE PT WAS TREATED WITH ANTIBIOTICS (TYPE UNKNOWN) FOR TWO WEEKS. ADVANCED BIONICS IS CURRENTLY IN THE PROCESS OF GATHERING MORE INFO. WHEN MORE INFO BECOMES AVAILABLE ADVANCED BIONICS WILL SUBMIT A SUPPLEMENTAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HIRES 90K | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS LLC | CI-1400-02H | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |