FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1811620
·
Received August 23, 2010
Report
- Report Number
- 6000034-2010-00550
- Event Type
- Injury
- Date Received
- August 23, 2010
- Date of Event
- May 23, 2009
- Report Date
- November 17, 2010
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
DURING DEVICE TESTING BY A BAXTER SERVICE TECHNICIAN, A COLLEAGUE INFUSION PUMP EXPERIENCED A FALSE UPSTREAM OCCLUSION ALARM. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY AS THIS EVENT DID NOT OCCUR DURING PATIENT USE. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS PUMP IS CURRENTLY UNKNOWN.
Description of Event or Problem · 1
PER THE CLINIC, THE PATIENT EXPERIENCED HEADACHES AND PAIN WITH STIMULATION RESULTING IN DEVICE NON-USE. ATTEMPTS TO CLINICALLY MANGE THE PATIENT WERE UNSUCCESSFUL. THE DEVICE WAS EXPLANTED ON (B)(6) 2010. THERE ARE NO PLANS TO REIMPLANT AS OF THE DATE OF THIS REPORT, (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | MCM | COCHLEAR LTD. | CI24RE (CA) | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 33 YR | Required Intervention |