FDA Adverse Event
Injury
Summary report: N
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 6107471
·
Received November 16, 2016
Report
- Report Number
- 6000034-2016-02212
- Event Type
- Injury
- Date Received
- November 16, 2016
- Report Date
- May 31, 2017
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- P840024
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
IMPLANTED DEVICE REMAINS.
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED ON JUNE 06, 2017.
Additional Manufacturer Narrative · 1
PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6), 2016, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY. THIS REPORT IS SUBMITTED (B)(6) 2016. DEVICE NOT RECEIVED BY MANUFACTURER.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED HEADACHES WITH AND WITHOUT DEVICE USE, RESULTING IN THE DECISION TO EXPLANT THE DEVICE. EXPLANTATION SURGERY IS SCHEDULED, HOWEVER, NOT YET CONFIRMED TO OCCUR. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NOT YET MADE AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 757579 | NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD. | CI22M | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |