FDA Adverse Event
Injury
Summary report: N
GRAVITATIONAL COMPENSATING ACCESSORY (GCA)
MDR report key: 224026
·
Received May 19, 1999
Report
- Report Number
- 9612007-1999-00010
- Event Type
- Injury
- Date Received
- May 19, 1999
- Report Date
- April 19, 1999
- Manufacturer
- NMT NEUROSCIENCES IMPLANTS S.A.
- Product Code
- JXG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
VALVE ACCESSORY WAS IMPLANTED AND EXPLANTED ON DIFFERENT PROCEDURES. MORE INFO HAS BEEN REQUESTED SEVERAL TIMES WITHOUT SUCCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GRAVITATIONAL COMPENSATING ACCESSORY (GCA) Implant | HYDROCEPHALUS VALVE | JXG | NMT NEUROSCIENCES IMPLANTS S.A. | NA | 20896095 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |