FDA Adverse Event
Injury
Summary report: N
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2942610
·
Received February 4, 2013
Report
- Report Number
- 6000034-2013-00188
- Event Type
- Injury
- Date Received
- February 4, 2013
- Date of Event
- September 23, 2009
- Report Date
- February 6, 2013
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 890024
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CORRECTION: PER THE CLINIC, THE REPORTED DEVICE WAS REGISTERED TO THE RECIPIENT IN ERROR. THE DEVICE HAS NOT BEEN EXPLANTED AND THE PATIENT REIMPLANTED AS PREVIOUSLY REPORTED. OWNERSHIP OF THE INTERNAL DEVICE IS UNDER INVESTIGATION. THIS REPORT IS FILED (B)(4) 2013. IMPLANTED DEVICE REMAINS.
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2009, FOR UNKNOWN REASONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(4) 2013. THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45906 | NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM, PRODUCT CODE; MCM | MCM | COCHLEAR LTD. | CI22M | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |