FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 3090722
·
Received May 2, 2013
Report
- Report Number
- 6000034-2013-00785
- Event Type
- Injury
- Date Received
- May 2, 2013
- Report Date
- June 18, 2013
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PER THE CLINIC, THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE ON (B)(6) 2013. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. (B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT WAS TREATED FOR AN INFECTION AT THE IMPLANT SITE USING IV ANTIBIOTICS AS WELL AS ORAL ANTIBIOTICS (NEITHER TYPE REPORTED). SUBSEQUENTLY, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXPLANT THE INTERNAL DEVICE (DATE NOT REPORTED). 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 |
|---|---|---|---|---|---|---|---|
| 191657 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | CI24RE (CA) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |