FDA Adverse Event
Malfunction
Summary report: N
MICROELECTRODE RECORDING PRODUCT
MDR report key: 17533377
·
Received August 12, 2023
Report
- Report Number
- MW5140281
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- October 7, 2013
- Manufacturer
- FHC, INC.
- Product Code
- GZL
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
A MEDTRONIC EMPLOYEE REPORTED THAT A CUSTOMER INFORMED THEM THAT THEY HAD A BAD ELECTRODE ON AN FHC MICROELECTRODE RECORDING PRODUCT. AN E-MAIL WAS SENT TO FCH AT [email protected] ON 4/18/2013 TO INFORM THEM OF THIS REPORTED COMPLAINT. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1215642 | MICROELECTRODE RECORDING PRODUCT | ELECTRODE, DEPTH | GZL | FHC, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |