FDA Adverse Event
Injury
Summary report: N
HIRES 90K ADVANTAGE IMPLANT
MDR report key: 4810550
·
Received May 29, 2015
Report
- Report Number
- 3006556115-2015-00240
- Event Type
- Injury
- Date Received
- May 29, 2015
- Date of Event
- May 15, 2015
- Report Date
- May 8, 2015
- Manufacturer
- ADVANCED BIONICS, LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NO INFORMATION
Narratives
Additional Manufacturer Narrative · 1
THE RECIPIENT REPORTEDLY EXPERIENCED SWELLING AFTER REPOSITION SURGERY. THE RECIPIENT DID NOT HAVE ANY MEDICAL INTERVENTION. THE RECIPIENT'S FAMILY WAS NOT SATISFIED WITH THE PLACEMENT OF THE DEVICE AND DECIDED TO HAVE A DIFFERENT SURGEON REPOSITION THE DEVICE. ON (B)(6) 2015, RECIPIENT UNDERWENT A SECOND REPOSITION SURGERY.
Additional Manufacturer Narrative · 1
ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE RECIPIENT HAS REPORTEDLY RESUMED USE OF THE DEVICE AND IS DOING WELL. THE RECIPIENT REMAINS IMPLANTED.
Description of Event or Problem · 1
THE COMPANY WAS INFORMED THAT THE RECIPIENT'S DEVICE HAD MIGRATED. SURGERY WAS PERFORMED TO REPOSITION THE RECIPIENT'S IMPLANTED DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 350819 | HIRES 90K ADVANTAGE IMPLANT | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS, LLC | CI-1500-04 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 MO | Required Intervention |