FDA Adverse Event
Injury
Summary report: N
CSF-CARDIAC/PERITONEAL CATHETER, STANDARD, 90CM
MDR report key: 182435
·
Received August 13, 1998
Report
- Report Number
- 2021898-1998-00073
- Event Type
- Injury
- Date Received
- August 13, 1998
- Date of Event
- March 26, 1996
- Report Date
- December 9, 1997
- Manufacturer
- MEDTRONIC PS MEDICAL
- Product Code
- JXG
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A SEVEN YEAR-OLD PT HAS EXPERIENCED FOUR INSTANCES OF PERITONEAL CATHETER FRACTURE, JUST BELOW THE LEVEL OF THE SHUNT VALVE. (MEDWATCH REPORT NUMBERS 2021898-1998-00003,-00073,-00074,00075.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CSF-CARDIAC/PERITONEAL CATHETER, STANDARD, 90CM Implant | CENTRAL NERVOUS SYSTEM FLUID SHUNTS AND COMPONENTS | JXG | MEDTRONIC PS MEDICAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR | Required Intervention |