FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3203653
·
Received July 3, 2013
Report
- Report Number
- 6000034-2013-01152
- Event Type
- Injury
- Date Received
- July 3, 2013
- Date of Event
- June 19, 2013
- Report Date
- July 24, 2014
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER CAREGIVERS
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED OCTOBER 15, 2014.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED WARM SENSATION AND INTERMITTENCIES WITH THE EXTERNAL COIL. THE DEVICE WAS REMOVED FROM SERVICE AND REPLACEMENT WAS SENT.NO REPORTS OF PATIENT INJURY ARE ASSOCIATED WITH THIS EVENT AND THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 305239 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD. | SP12 COIL/CABLE | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Required Intervention |