FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CONTOUR
MDR report key: 8246282
·
Received January 14, 2019
Report
- Report Number
- 6000034-2019-00035
- Event Type
- Injury
- Date Received
- January 14, 2019
- Report Date
- February 5, 2019
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS SUBMITTED ON JANUARY 15, 2019, BY COCHLEAR LIMITED ON BEHALF OF (B)(4). EXEMPTION NUMBER E2016011.
Description of Event or Problem · 0
PER THE AUDIOLOGIST, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH DEVICE USE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2018 AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED ON MARCH 05, 2019.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 39263 | NUCLEUS 24 CONTOUR | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI24R (CS) | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |