FDA Adverse Event
Malfunction
Summary report: N
OJEMAN CORTICAL STIMULATOR
MDR report key: 2020386
·
Received February 8, 2011
Report
- Report Number
- 1222895-2011-00003
- Event Type
- Malfunction
- Date Received
- February 8, 2011
- Report Date
- February 8, 2011
- Manufacturer
- INTEGRA RADIONICS, INC.
- Product Code
- ETN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.
Description of Event or Problem · 1
AN OJEMAN CORTICAL STIMULATOR (OCS2) WAS IN CONTACT WITH A PATIENT WHEN THE STIMULATION STOPPED. IT IS UNKNOWN WHETHER THERE WAS ANY PATIENT INJURY INVOLVED WITH THIS COMPLAINT. THE EVENT DID NOT LEAD TO AN INCREASE IN THE SURGERY TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OJEMAN CORTICAL STIMULATOR | NA | ETN | INTEGRA RADIONICS, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |