FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2817893
·
Received November 2, 2012
Report
- Report Number
- 6000034-2012-02116
- Event Type
- Injury
- Date Received
- November 2, 2012
- Date of Event
- November 1, 2012
- Report Date
- July 22, 2013
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS NOT AVAILABLE FOR ANALYSIS AS OF THE DATE OF THIS REPORT, OCTOBER 16, 2013. THIS REPORT IS FILED OCTOBER 16, 2013.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, IMAGING (DATE AND TYPE NOT REPORTED) INDICATED THAT THE ELECTRODE ARRAY WAS PARTIALLY EXTRUDED FROM THE COCHLEA. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED A TINGLING SENSATION ON THE TONGUE, AND THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2012. THERE ARE PLANS TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE, BUT IT IS UNKNOWN IF THIS HAS OCCURRED AS OF THE DATE OF THIS REPORT, (B)(4) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | CI24M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |