FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2830837
·
Received November 13, 2012
Report
- Report Number
- 6000034-2012-02182
- Event Type
- Malfunction
- Date Received
- November 13, 2012
- Date of Event
- November 6, 2012
- Report Date
- June 5, 2013
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED MIGRATION OF THE RECEIVER/STIMULATOR SUBSEQUENT TO PLACEMENT OF A "TIGHT-FITTING HELMET" ON THE PATIENT'S HEAD, APPROXIMATELY ON WEEK AFTER IMPLANTATION. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2012, DURING WHICH THE DEVICE WAS EXPLANTED AND THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | CI422 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 MO | Required Intervention |