FDA Adverse Event
Injury
Summary report: N
NI
MDR report key: 3060074
·
Received April 11, 2013
Report
- Report Number
- 3006556115-2013-00152
- Event Type
- Injury
- Date Received
- April 11, 2013
- Date of Event
- March 22, 2013
- Report Date
- March 22, 2013
- Manufacturer
- ADVANCED BIONICS, LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CSF LEAK DURING INITIAL IMPLANT SURGERY. THE CSF LEAK WAS REPAIRED AND THE PATIENT WAS SUCCESSFULLY IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 155311 | NI | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS, LLC | NI | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |