FDA Adverse Event
Injury
Summary report: N
DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5
MDR report key: 2113780
·
Received June 2, 2011
Report
- Report Number
- 2021898-2011-00122
- Event Type
- Injury
- Date Received
- June 2, 2011
- Date of Event
- May 9, 2011
- Report Date
- May 9, 2011
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- PMA / PMN Number
- K902783
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE, AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL OF OUR VALVES ARE 100% TESTED AT THE TIME OF MANUFACTURE.
Description of Event or Problem · 1
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A SHUNT REVISION OCCURRED. ACCORDING TO THE REPORT, THE SHUNT WAS IMPLANTED NEARLY THREE YEARS AGO, BUT RECENTLY, THE DOCTOR ALLEGEDLY FOUND THAT THE SHUNT DRAINED POORLY. THE DOCTOR SUSPECTED IT WAS DUE TO A PROBLEM WITH THE VALVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5 | JXG | MEDTRONIC NEUROSURGERY | C16434 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |