FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2231896
·
Received September 1, 2011
Report
- Report Number
- 6000034-2011-00648
- Event Type
- Malfunction
- Date Received
- September 1, 2011
- Date of Event
- August 12, 2011
- Report Date
- August 21, 2012
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
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; DURING THE SAME SURGERY THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE.THIS REPORT IS FILED (B)(6), 2011.
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. THIS REPORT IS FILED (B)(4) 2012.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF CONNECTION TO THE INTERNAL DEVICE AFTER REPORTEDLY DRIVING UNDER A STREET LIGHT. THE IMPLANTED DEVICE REMAINS. THERE ARE PLANS TO EXPLANT THE DEVICE AND TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE BUT THIS HAS NOT OCCURRED AS OF THE DATE 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 | MCM | COCHLEAR LTD. | CI512 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention |