FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1971958
·
Received January 27, 2011
Report
- Report Number
- 6000034-2011-00058
- Event Type
- Malfunction
- Date Received
- January 27, 2011
- Date of Event
- January 20, 2011
- Report Date
- June 22, 2011
- 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
(B)(4): IMPLANTED DEVICE REMAINS.
Additional Manufacturer Narrative · 1
PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6), 2011; DURING THE SAME SURGERY THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE. THIS REPORT IS FILED (B)(4), 2011.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT REPORTED INTERMITTENT CONTACT WITH THE INTERNAL DEVICE. IT IS UNKNOWN WHETHER THERE ARE PLANS TO EXPLANT AND REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT, (B)(6), 2011. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM, PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | CI512 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR | Required Intervention |