FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.
MDR report key: 4133230
·
Received October 1, 2014
Report
- Report Number
- 6000034-2014-01383
- Event Type
- Malfunction
- Date Received
- October 1, 2014
- Date of Event
- September 15, 2014
- Report Date
- March 11, 2015
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2015 AND THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE DURING THE SAME PROCEDURE. THIS REPORT IS FILED MARCH 27TH, 2015.
Additional Manufacturer Narrative · 1
(B)(4). THE IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED INTERMITTENCIES AND SUBSEQUENT LOSS OF CONNECTION TO THE INTERNAL DEVICE; THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 611700 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. | MCM | MCM | COCHLEAR LTD. | CI512 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR | Required Intervention |