FDA Adverse Event
Malfunction
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1946138
·
Received January 4, 2011
Report
- Report Number
- 6000034-2010-00828
- Event Type
- Malfunction
- Date Received
- January 4, 2011
- Date of Event
- December 7, 2010
- Report Date
- May 18, 2011
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- AUDIOLOGIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). IMPLANTED DEVICE REMAINS.
Additional Manufacturer Narrative · 1
PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6), 2010; DURING THE SAME SURGERY THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE. THIS REPORT IS FILED (B)(4), 2011.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT SUSTAINED A SEVERE BLOW TO THE HEAD DURING AN AUTOMOBILE ACCIDENT, RESULTING IN A 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), 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. | CI24R (CS) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Required Intervention |