FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 4884804
·
Received July 1, 2015
Report
- Report Number
- 6000034-2015-01064
- Event Type
- Malfunction
- Date Received
- July 1, 2015
- Date of Event
- June 5, 2015
- Report Date
- August 31, 2015
- Manufacturer
- COCHLEAR LTD .
- Product Code
- MCM
- PMA / PMN Number
- 890027
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED OCTOBER 23, 2015.
Additional Manufacturer Narrative · 1
CORRECTION: (B)(4). THIS REPORT IS FILED OCTOBER 23, 2015.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED POOR SOUND QUALITY WITH DEVICE USE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED (B)(6) 2015, 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 |
|---|---|---|---|---|---|---|---|
| 428382 | NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM, PRODUCT CODE: MCM | MCM | COCHLEAR LTD . | CI22M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Required Intervention |