FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CONTOUR
MDR report key: 8251265
·
Received January 15, 2019
Report
- Report Number
- 6000034-2019-00022
- Event Type
- Malfunction
- Date Received
- January 15, 2019
- Date of Event
- November 19, 2018
- Report Date
- January 22, 2019
- Manufacturer
- COCHLEAR LTD
- Product Code
- MCM
- PMA / PMN Number
- P970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS REPORT IS FILED ON JANUARY 31, 2019. - ATTACHMENT: [133673 - DEVICE ANALYSIS REPORT REG.PDF].
Additional Manufacturer Narrative · 1
THIS REPORT IS SUBMITTED ON JANUARY 16, 2019.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED PAIN, NON-AUDITORY SENSATIONS AND A PERFORMANCE DECREMENT WITH DEVICE USE, AND SUBSEQUENTLY WAS TREATED WITH ORAL ANTIBIOTICS. THE ISSUE COULD NOT BE RESOLVED, THE DEVICE WAS EXPLANTED ON (B)(6) 2018 AND THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 40102 | NUCLEUS 24 CONTOUR | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD | CI24R (CS) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Required Intervention |