FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3192774
·
Received June 27, 2013
Report
- Report Number
- 6000034-2013-01125
- Event Type
- Malfunction
- Date Received
- June 27, 2013
- Date of Event
- June 14, 2013
- Report Date
- June 30, 2013
- Manufacturer
- COCHLEAR LTD .
- Product Code
- MCM
- PMA / PMN Number
- 890027
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4): IMPLANTED DEVICE REMAINS.
Additional Manufacturer Narrative · 1
PER THE PATIENTS SURGEON, THE DEVICE WAS EXPLANTED (B)(6) 2013; THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY. THIS REPORT FILED JANUARY 16, 2014.
Description of Event or Problem · 1
PER THE CLINIC, NO CONNECTION COULD BE MADE TO THE INTERNAL DEVICE, AND THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS.THERE ARE PLANS TO EXPLANT THE DEVICE AND TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE, HOWEVER IT IS UNKNOWN IF THIS HAS OCCURRED AS OF THE DATE OF THIS REPORT, (B)(6), 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 293804 | NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM, PRODUCT CODE: MCM | MCM | COCHLEAR LTD . | CI22M | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Required Intervention |