FDA Adverse Event
Malfunction
Summary report: N
JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
MDR report key: 2181141
·
Received July 8, 2011
Report
- Report Number
- 2021898-2011-00142
- Event Type
- Malfunction
- Date Received
- July 8, 2011
- Date of Event
- June 16, 2011
- Report Date
- June 17, 2011
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- PMA / PMN Number
- K902783
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. THEREFORE, AN EVALUATION OF THE PRODUCT WAS NOT POSSIBLE. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.
Description of Event or Problem · 1
MEDTRONIC NEUROSURGERY RECEIVED A REPORT FROM A FAMILY MEMBER OF A PT THAT HAD A SHUNT IMPLANTED IN (B)(6) 2010. ACCORDING TO THE REPORT, THE PT WAS ADMITTED TO THE HOSPITAL IN (B)(6) 2011 BECAUSE HER SYMPTOMS OF HYDROCEPHALUS BECAME WORSE. ALLEGEDLY, THE PT WAS IN A COMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS | JXG | MEDTRONIC NEUROSURGERY | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |