FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2970835
·
Received February 20, 2013
Report
- Report Number
- 6000034-2013-00355
- Event Type
- Injury
- Date Received
- February 20, 2013
- Date of Event
- January 28, 2013
- Report Date
- May 31, 2013
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
DUE TO MISCOMMUNICATION THE FOLLOWING STATEMENT NEEDS TO BE CORRECTED: THE EQUIPMENT STAYS IN USE; IT WAS NOT ADVISED TO BE REMOVED FROM SERVICE AND NO REPLACEMENT WAS SENT AS PREVIOUSLY REPORTED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER; AS PREVIOUSLY REPORTED. PER THE CLINIC, THE ISSUE COULD BE RESOLVED AND THE PATIENT RESUMED USE OF DEVICE. NO REPORTS OF PATIENT INJURY ARE ASSOCIATED WITH THIS EVENT. THIS REPORT IS FILED (B)(4) 2013. FUNCTIONING DEVICE, NO ANALYSIS REQUIRED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED WARM SENSATION WITH EXTERNAL DEVICE USE. THE EQUIPMENT WAS ADVISED TO BE REMOVED FROM SERVICE AND A REPLACEMENT WAS SENT. NO REPORTS OF PATIENT INJURY ARE ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 74533 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD | CP800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |