FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2222194
·
Received August 24, 2011
Report
- Report Number
- 6000034-2011-00630
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Date of Event
- August 8, 2011
- Report Date
- December 8, 2011
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
CORRECTION: THE CORRECT DATE OF EXPLANT IS (B)(6) 2011; NOT (B)(6) 2011 AS PREVIOUSLY REPORTED. (B)(4).
Additional Manufacturer Narrative · 1
THIS REPORT IS FILED (B)(4), 2011.
Additional Manufacturer Narrative · 1
(B)(4): IMPLANTED DEVICE REMAINS.
Additional Manufacturer Narrative · 1
PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6), 2011; THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY. THIS REPORT IS FILED (B)(4), 2011.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A SUDDEN LOSS OF CONNECTION TO THE INTERNAL DEVICE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS. EXPLANT AND REIMPLANTATION IS PLANNED BUT HAS NOT TAKEN PLACE AT THE TIME OF THIS REPORT (B)(6), 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM, PRODUCT CODE: MCM | MCM | COCHLEAR LTD. | CI512 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |