FDA Adverse Event
Injury
Summary report: N
HIRES 90K
MDR report key: 1901410
·
Received November 2, 2010
Report
- Report Number
- 3006556115-2010-00523
- Event Type
- Injury
- Date Received
- November 2, 2010
- Date of Event
- October 11, 2010
- Report Date
- October 12, 2010
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE PT REPORTEDLY FELL ON THE STONE STAIRS. THE PT'S DEVICE WAS EXPLANTED. THE PT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS DEVICE.
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 | 7 YR | Required Intervention |