FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3171039
·
Received June 14, 2013
Report
- Report Number
- 6000034-2013-01050
- Event Type
- Malfunction
- Date Received
- June 14, 2013
- Date of Event
- May 30, 2013
- Report Date
- November 6, 2013
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED DECEMBER 16, 2013.
Additional Manufacturer Narrative · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2013; THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY. THIS REPORT IS FILED OCTOBER 16, 2013.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT REPORTED OVERLY LOUD SOUNDS AND "SHOCKING SENSATION" WITH DEVICE USE. THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED (B)(6) 2013, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271470 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD | CI512 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |