FDA Adverse Event
Injury
Summary report: N
HIRES 90K ADVANTAGE IMPLANT
MDR report key: 4823707
·
Received June 4, 2015
Report
- Report Number
- 3006556115-2015-00254
- Event Type
- Injury
- Date Received
- June 4, 2015
- Date of Event
- August 17, 2015
- Report Date
- May 17, 2015
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE RECIPIENT UNDERWENT REPOSITIONING SURGERY ON (B)(6) 2015. ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE RECIPIENT HAS REPORTEDLY RESUMED USE OF THE DEVICE. THE RECIPIENT REMAINS IMPLANTED. THIS IS THE FINAL REPORT.
Description of Event or Problem · 1
THE RECIPIENT'S ELECTRODE HAS REPORTEDLY MIGRATED. REPOSITIONING SURGERY WILL BE SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 363481 | HIRES 90K ADVANTAGE IMPLANT | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS LLC | CI-1500-01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Required Intervention |