FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3245236
·
Received July 24, 2013
Report
- Report Number
- 6000034-2013-01364
- Event Type
- Injury
- Date Received
- July 24, 2013
- Report Date
- October 28, 2013
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4) IMPLANTED DEVICE REMAINS.
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED NOVEMBER 27, 2013.
Additional Manufacturer Narrative · 1
PER THE PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2013 AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY. THIS REPORT IS FILED OCTOBER 23, 2013.
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. EXPLANT AND REIMPLANTATION IS PLANNED BUT HAS NOT TAKEN PLACE AT THE TIME OF THIS REPORT (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 346685 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD | CI512 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |