FDA Adverse Event
Injury
Summary report: N
RIGHT ANGLE GUIDE
MDR report key: 398784
·
Received June 11, 2002
Report
- Report Number
- 9612007-2002-00007
- Event Type
- Injury
- Date Received
- June 11, 2002
- Report Date
- May 15, 2002
- Manufacturer
- NMT NEUROSCIENCES IMPLANTS S.A.
- Product Code
- JXG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DR. INDICATED THAT HE HAS EXPERIENCED SEVERAL CASES IN WHICH THE RIGHT-ANGLE GUIDE USED TO MAKE THE RIGHT-ANGLE CATHETER BENT IN THE VENTRICULAR CATHETER OF AN NMT HAKIM SHUNT HAD MOVED CAUSING A KINK IN THE CATHETER. HE INDICATED HE ANCHORS THE GUIDE BUT INDICATED HE MAKES A BURR HOLE RATHER THAN A TWIST DRILL HOLE AND HE BELIEVES THAT THIS IS WHY HE HAS EXPERIENCED MOVEMENT. HE SUBSTITUTES A RIGHT ANGLE CONNECTOR WHICH HE LIKE. HE ADMITTED THAT HE TRAINED ON A CORDIS HAKIM VALVE WHEN THE SYSTEM INCLUDED THE RIGHT-ANGLE CONNECTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIGHT ANGLE GUIDE | HYDROCEPHALUS SHUNT COMPONENT | JXG | NMT NEUROSCIENCES IMPLANTS S.A. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |