FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2091939
·
Received May 18, 2011
Report
- Report Number
- 6000034-2011-00350
- Event Type
- Injury
- Date Received
- May 18, 2011
- Date of Event
- May 12, 2011
- Report Date
- September 18, 2012
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2011; DURING THE SAME SURGERY THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE. THIS REPORT IS FILED (B)(6) 2011.
Additional Manufacturer Narrative · 1
(B)(4). THE IMPLANTED DEVICE REMAINS.
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED (B)(4) 2012.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT REPORTED PAIN WITH DEVICE USE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE PATIENT WAS SEDATED USING IV SEDATION TO COMPLETE AN INTEGRITY TEST. 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. | CI24RE (CA) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 YR | Required Intervention |