FDA Adverse Event
Malfunction
Summary report: N
HIRES 90K IMPLANT
MDR report key: 3772207
·
Received January 2, 2014
Report
- Report Number
- 3006556115-2014-00609
- Event Type
- Malfunction
- Date Received
- January 2, 2014
- Date of Event
- November 28, 2014
- Report Date
- November 28, 2014
- Manufacturer
- ADVANCED BIONICS LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
THE PT'S DEVICE WAS EXPLANTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S DEVICE TESTING REVEALED SEVERAL OPEN AND SHORTED ELECTRODES. THE SURGEON IS PURSUING DEVICE REVISION. THE SURGERY WILL BE SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2800 | HIRES 90K IMPLANT | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS LLC | CI-1400-01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |