FDA Adverse Event
Injury
Summary report: N
HIRES 90K
MDR report key: 2243529
·
Received August 30, 2011
Report
- Report Number
- 3006556115-2011-00410
- Event Type
- Injury
- Date Received
- August 30, 2011
- Date of Event
- August 3, 2011
- Report Date
- August 9, 2011
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADVANCED BIONICS CONSIDERS INVESTIGATION INTO THIS EVENT AS CLOSED. THE COMPANY WAS INFORMED THAT THE PT IS DOING WELL. THE PT'S DEVICE REMAINS IMPLANTED. THIS IS FINAL REPORT.
Description of Event or Problem · 1
THE COMPANY WAS MADE AWARE THAT ELECTRODE REINSERTION WAS PERFORMED ON PT WITHOUT COMPLICATION. TESTING OF THE DEVICE REVEALED THAT THE DEVICE IS FUNCTIONING NORMALLY.
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 | 7 YR | Required Intervention |