FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1905163
·
Received November 22, 2010
Report
- Report Number
- 6000034-2010-00722
- Event Type
- Malfunction
- Date Received
- November 22, 2010
- Date of Event
- November 19, 2010
- Report Date
- October 25, 2011
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- 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 ANOTHER DEVICE. THIS REPORT IS FILED (B)(4), 2011.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED A BLOW TO THE HEAD AND SUBSEQUENT LOSS OF CONNECTION TO THE INTERNAL DEVICE. EXPLANT AND REIMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT (B)(6), 2010. THE IMPLANTED DEVICE REMAINS.
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. | CI24R (CS) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 YR | Required Intervention |