FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 2223687
·
Received August 25, 2011
Report
- Report Number
- 6000034-2011-00634
- Event Type
- Injury
- Date Received
- August 25, 2011
- Date of Event
- July 22, 2011
- Report Date
- July 6, 2012
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6), 2011; THE SURGEON PLANS FOR REIMPLANTATION TWO TO THREE MONTHS POST EXPLANT TO ALLOW INFECTION TIME TO RESOLVE.THIS REPORT IS FILED (B)(6), 2011.
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4): IMPLANTED DEVICE REMAINS.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT DEVELOPED IN INFECTION AROUND THE IMPLANT SITE. ANTIBIOTIC TREATMENT (TYPE AND DATE NOT REPORTED) WAS ADMINISTERED BUT THIS DID NOT ALLEVIATE THE PROBLEM. THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6), 2011 TO ROTATE SKIN FLAP. 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 (ST) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR | Required Intervention |