FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24
MDR report key: 8881854
·
Received August 11, 2019
Report
- Report Number
- 6000034-2019-01386
- Event Type
- Injury
- Date Received
- August 11, 2019
- Report Date
- November 12, 2019
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS EXPLANTED ON (B)(6) 2019. THIS REPORT IS SUBMITTED 04 NOVEMBER 2019.
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED 3 DECEMBER 2019. - ATTACHMENT: [155771 DEVICE ANALYSIS REPORT.PDF].
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON AUGUST 12, 2019.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED INTERMITTENT SWELLING OVER THE RECEIVER STIMULATOR WHICH HAS NOT BEEN RESOLVED WITH MEDICAL MANAGEMENT. THE SURGEON HAS DETERMINED THAT AN INFECTION IS PRESENT BASED ON THE PRESENCE OF SWELLING. NO ANTIBIOTICS WAS ADMINISTERED. THE IMPLANTED DEVICE REMAINS. THE SURGEON HAS NOT DECIDED UPON THE COURSE OF ACTION AT OF THE DATE OF THIS REPORT, AUGUST 12, 2019.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 675761 | NUCLEUS 24 | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI24M | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |