FDA Adverse Event
Injury
Summary report: N
HIRES 90K IMPLANT
MDR report key: 3192914
·
Received June 25, 2013
Report
- Report Number
- 3006556115-2013-00287
- Event Type
- Injury
- Date Received
- June 25, 2013
- Date of Event
- June 10, 2013
- Report Date
- June 4, 2013
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE PATIENT'S DEVICE WAS SUCCESSFULLY REPOSITIONED. THE PATIENT'S DEVICE REMAINS IMPLANTED AND THE PATIENT IS REPORTEDLY HEARING WELL. THIS IF THE FINAL REPORT.
Description of Event or Problem · 1
THE PATIENT'S DEVICE REPORTEDLY MIGRATED OUT OF THE BONE BED AFTER A TRAUMA. SURGERY TO REPOSITION THE DEVICE WAS SUCCESSFULLY COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 288998 | HIRES 90K IMPLANT | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS LLC | CI-1400-01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Required Intervention |