UNKNOWN VALVE/SHUNT
Report
- Report Number
- 2021898-2017-00330
- Event Type
- Injury
- Date Received
- June 16, 2017
- Report Date
- May 19, 2017
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PATIENT
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT ONLY HAD ONE VALVE EXPLANTED, NOT TWO. THIS MANUFACTURER REPORT ORIGINALLY REPRESENTED A SECOND VALVE OF THE PATIENT, WHEREAS THE OTHER VALVE WAS CAPTURED IN MANUFACTURER REPORT #2021898-2017-00327. PLEASE REFERENCE THIS REPORT FOR INFORMATION REGARDING THE ISSUES EXPERIENCED WITH THEIR EXPLANTED VALVE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT ONLY HAD ONE VALVE EXPLANTED, NOT TWO. THIS MANUFACTURER REPORT ORIGINALLY REPRESENTED A SECOND VALVE OF THE PATIENT, WHEREAS THE OTHER VALVE WAS CAPTURED IN MANUFACTURER REPORT #2021898-2017-00327. PLEASE REFERENCE THIS REPORT FOR INFORMATION REGARDING THE ISSUES EXPERIENCED WITH THEIR EXPLANTED VALVE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT DEVELOPED AN INFECTION. ACCORDING TO THE REPORT, THE VALVE WAS REPLACED. REPORTEDLY, THE PATIENT'S STATUS WAS ALIVE-NO INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 429237 | UNKNOWN VALVE/SHUNT | SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS | JXG | MEDTRONIC NEUROSURGERY | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |