FDA Adverse Event
Injury
Summary report: N
HAKIM VALVE
MDR report key: 400324
·
Received June 20, 2002
Report
- Report Number
- 9612007-2002-00009
- Event Type
- Injury
- Date Received
- June 20, 2002
- Date of Event
- February 22, 2002
- Report Date
- May 24, 2002
- Manufacturer
- NMT NEUROSCIENCES IMPLANTS S.A.
- Product Code
- JXG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A REPORT FROM THE FIELD INDICATED THAT DURING A SURGICAL HYDROCEPHALUS VALVE REVISION, THE VENTRICULAR CATHETER WAS FOUND BROKEN. NO ADDITIONAL INFORMATION COULD BE OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HAKIM VALVE | HYDROCEPHALUS VALVE | JXG | NMT NEUROSCIENCES IMPLANTS S.A. | NA | 110736 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |