FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2090131
·
Received May 16, 2011
Report
- Report Number
- 6000034-2011-00348
- Event Type
- Malfunction
- Date Received
- May 16, 2011
- Date of Event
- May 13, 2011
- Report Date
- February 13, 2012
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DEVICE NOT AVAILABLE FOR ANALYSIS.
Additional Manufacturer Narrative · 1
DEVICE COIL IS NOT AVAILABLE FOR ANALYSIS. THIS REPORT IS FILED (B)(4) 2012. COIL NOT AVAILABLE FOR ANALYSIS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT REPORTED THAT THE EXTERNAL TRANSMITTER COIL BECAME HOT DURING USE. THERE WERE NO REPORTS OF PATIENT INJURY. THE INCIDENT IS UNDER INVESTIGATION AND THE DEVICE HAS BEEN REMOVED FROM SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD. | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR | Required Intervention |