FDA Adverse Event
Malfunction
Summary report: N
OSV II
MDR report key: 1660967
·
Received April 12, 2010
Report
- Report Number
- 9612007-2010-00003
- Event Type
- Malfunction
- Date Received
- April 12, 2010
- Report Date
- April 13, 2010
- Product Code
- JXG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.
Description of Event or Problem · 1
AN INITIAL REPORT WAS RECEIVED THAT OSVII WAS DEFECTIVE OR MALFUNCTIONED. THE INCIDENT WAS DESCRIBED AS FOLLOWS; AN OSVII WAS PLACED IN (B)(6) 2009. ON (B)(6), 2010, A REVISION WAS DONE. THE PATIENTS' VENTRICLES WERE FOUND TO BE ENLARGED. THE PEDIATRIC NEURO SURGEON DETERMINED THAT THE VENTRICULAR CATHETER AND PERITONEAL CATHETER WERE PT SO HE BELIEVES THAT THE VALVE MALFUNCTIONED OR IS DEFECTIVE. THE PT DID NOT INCUR ANY ADVERSE EFFECTS RELATED TO THIS INCIDENT. ADD'L CLINICAL HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OSV II | OSV II | JXG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 MO |