FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3130623
·
Received May 24, 2013
Report
- Report Number
- 6000034-2013-00978
- Event Type
- Malfunction
- Date Received
- May 24, 2013
- Date of Event
- May 17, 2013
- Report Date
- October 10, 2013
- 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
THIS REPORT IS FILED NOVEMBER 29, 2013.
Additional Manufacturer Narrative · 1
(B)(4): IMPLANTED DEVICE REMAINS.
Additional Manufacturer Narrative · 1
PER THE SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2013; DURING THE SAME SURGERY THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE. (B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED INTERMITTENCIES AND SUBSEQUENT LOSS OF CONNECTION TO THE INTERNAL DEVICE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS. THERE ARE PLANS TO EXPLANT THE DEVICE AND TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE; HOWEVER, THIS HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT, (B)(4) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231259 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | PRODUCT CODE: MCM | MCM | COCHLEAR LTD | CI512 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Required Intervention |