FDA Adverse Event
Injury
Summary report: N
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
MDR report key: 1081506
·
Received July 23, 2008
Report
- Report Number
- 6000034-2008-00400
- Event Type
- Injury
- Date Received
- July 23, 2008
- Date of Event
- August 1, 2001
- Report Date
- November 29, 2002
- Manufacturer
- COCHLEAR LTD.
- Product Code
- MCM
- PMA / PMN Number
- 970051
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS A FINAL REPORT. THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.
Description of Event or Problem · 1
PER THE AUDIOLOGIST, IN 2001, THE PT PRESENTED WITH AN ABSCESS DUE TO AN INFECTION. ON THREE MONTHS LATER, THE PT'S DEVICE WAS EXPLANTED AND THE INFECTED SITE WAS DEBRIDED. THE PT WAS REIMPLANTED DURING THE SAME SURGERY. THE PT'S DEVICE WAS EXPLANTED IN 2002, AND A NEW DEVICE WAS REIMPLANTED DURING THE SAME SURGERY. THAT DEVICE WAS ALSO EXPLANTED (REPORTED IN A PREVIOUS MDR 6000034-2006-00271).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM | MCM | COCHLEAR LTD. | CI24M | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |