FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2220997
·
Received August 23, 2011
Report
- Report Number
- 6000034-2011-00626
- Event Type
- Malfunction
- Date Received
- August 23, 2011
- Date of Event
- July 15, 2011
- Report Date
- November 22, 2011
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2011; IT IS UNKNOWN IF THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE. (B)(4). THIS REPORT IS FILED (B)(4) 2012.
Additional Manufacturer Narrative · 1
(B)(4): IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, AFTER A YEAR OF SUCCESSFUL IMPLANT USE THE PATIENT EXPERIENCED INTERMITTENCIES AND SUBSEQUENT LOSS OF CONNECTION TO THE INTERNAL DEVICE. THE IMPLANTED DEVICE REMAINS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM, PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | CI512 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 MO | Required Intervention |