FDA Adverse Event
Other
Summary report: N
UNKNOWN VALVE/SHUNT
MDR report key: 2564058
·
Received May 1, 2012
Report
- Report Number
- 2021898-2012-00100
- Event Type
- Other
- Date Received
- May 1, 2012
- Report Date
- April 1, 2012
- Manufacturer
- MEDTRONIC NEUROSURGERY
- Product Code
- JXG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS UNAVAILABLE FOR RETURN AS IT REMAINS IMPLANTED. THEREFORE AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS WAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ACCORDING TO THE INSTRUCTIONS FOR USE THAT ACCOMPANIES THE DEVICE, "THE PT MAY RARELY EXHIBIT A REACTION DUE TO SENSITIVITY TO THE IMPLANT."
Description of Event or Problem · 1
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT A PT DEVELOPED A RED RASH AROUND THE CATHETER PATHWAY DUE TO A SILICONE ALLERGY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN VALVE/SHUNT | JXG - SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS | JXG | MEDTRONIC NEUROSURGERY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |