STRATA NSC LUMBOPERITONEAL SHUNT KIT
Report
- Report Number
- 2021898-2017-00590
- Event Type
- Injury
- Date Received
- November 27, 2017
- Report Date
- February 28, 2018
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- UDI-DI
- 00643169010789
- PMA / PMN Number
- K091312
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE INFECTIONS WAS UNKNOWN, HOWEVER IT WAS NOTED THE INFECTIONS WERE NOT RELATED TO THE DEVICE. THE PATIENT UNDERWENT AN IMPLANT OF A VENTRICULOPERITONEAL SHUNT IN LATE (B)(6) 2018. THE PATIENT¿S STATUS WAS GOOD.
IT WAS REPORTED THAT A LUMBAR-PERITONEAL SHUNT PROCEDURE WAS PERFORMED USING THE VALVE AND CATHETER. AFTER THAT, AS THERE WAS A POSSIBILITY OF INFECTION, THE VALVE AND CATHETER WERE REMOVED FROM THE PATIENT'S BODY DUE TO BEING OCCLUDED. IT WAS NOTED THAT DURING THE PROCEDURE, THE ABDOMINAL CATHETER WAS OUTSIDE OF THE ASEPTIC FIELD SO ANOTHER ABDOMINAL CATHETER WAS USED INSTEAD. IT WAS STATED THAT THE WHOLE SYSTEM WAS REMOVED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S INFECTION WAS (B)(6) AND BACILLUS CEREUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 839140 | STRATA NSC LUMBOPERITONEAL SHUNT KIT | SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS | JXG | MEDTRONIC NEUROSURGERY | 44421 | E27073 | 00643169010789 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |