FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2032653
·
Received March 29, 2011
Report
- Report Number
- 6000034-2011-00200
- Event Type
- Injury
- Date Received
- March 29, 2011
- Date of Event
- March 4, 2011
- Report Date
- July 4, 2012
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED DUE TO THE INAPPROPRIATE PLACEMENT OF THE ELECTRODE ARRAY. THE DEVICE WAS EXPLANTED ON (B)(6), 2010 AND THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE DURING THE SAME SURGERY. THE DEVICE WAS RECEIVED AT THE MANUFACTURER WITHOUT DOCUMENTATION AND WAS SUBSEQUENTLY DETERMINED TO BE AN EXPLANT RATHER THAN A SURGICAL REJECT.
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 YR | Required Intervention |