CERTAS INLIN VLV ONLY W/SPHNGD
Report
- Report Number
- 1226348-2013-32529
- Event Type
- Injury
- Date Received
- November 5, 2013
- Report Date
- February 24, 2012
- Manufacturer
- CODMAN & SHURTLEFF, INC MEDOS
- Product Code
- JXG
- PMA / PMN Number
- PK112156
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE REMAINS IMPLANTED.
IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.
COMPLAINT PERTAINS TO (B)(4). IT HAS BEEN DECIDED THAT THE COMPLAINT IS REPORTABLE. AS A RESULT A MEDWATCH REPORT IS BEING FILED. REP REPORTED THAT SHE RECEIVED A CALL FROM SURGEON ON (B)(6) 2011 AND HE STATED THAT HE WAS HAVING TROUBLE VERIFYING THE CERTAS VALVE SETTING (B)(4) WITH THE VERIFICATION TOOL. THE PROCEDURE HAD TAKEN PLACE ON (B)(6) 2012 AND THE PATIENTS SCALP WAS SWOLLEN FROM THE PROCEDURE, AND THE PATIENT ALSO HAD SEVERAL PREVIOUS PROCEDURES THAT CAUSED SCAR TISSUE BELOW THE INCISION SITE. REP WENT IN TO MEET WITH SURGEON SO SHE COULD HELP GUIDE HIM THROUGH THE VERIFICATION PROCESS. THE VERIFICATION TOOL WAS SPINNING AND READING VARIOUS INACCURATE SETTINGS. SURGEON HAD CALLED FOR X-RAYS PRIOR TO MY ARRIVAL, BUT BECAUSE THE VALVE DOES NOT HAVE ANY ORIENTATION MARKERS, WE WERE NOT ABLE TO VERIFY WHERE THE VALVE WAS SET BASED ON THE X-RAYS THAT HAD BEEN TAKEN. ONCE WE WERE ABLE TO VERIFY THAT THE X-RAY HAD BEEN TAKEN PROPERLY, WE WERE ABLE TO VERIFY THE VALVE SETTING. THE PATIENT WAS DOING WELL THROUGHOUT THE PROCESS, AS SURGEON STATES IN HIS EMAIL BELOW. THESE EVENTS HAPPENED OVER THE COURSE OF FOUR DAYS, (B)(6) 2011.
A FOLLOW UP REPORT IS BEING FILED AS THE INITIAL REPORTING DECISION HAS CHANGED. THE COMPLAINT IS NOW BEING FILED AS A SERIOUS INJURY. REP REPORTED THAT SHE RECEIVED A CALL FROM SURGEON ON 12/18/2011 AND HE STATED THAT HE WAS HAVING TROUBLE VERIFYING THE CERTAS VALVE SETTING (82-8804) WITH THE VERIFICATION TOOL. THE PROCEDURE HAD TAKEN PLACE ON (B)(6) 2012 AND THE PATIENTS SCALP WAS SWOLLEN FROM THE PROCEDURE, AND THE PATIENT ALSO HAD SEVERAL PREVIOUS PROCEDURES THAT CAUSED SCAR TISSUE BELOW THE INCISION SITE. REP WENT IN TO MEET WITH SURGEON SO SHE COULD HELP GUIDE HIM THROUGH THE VERIFICATION PROCESS. THE VERIFICATION TOOL WAS SPINNING AND READING VARIOUS INACCURATE SETTINGS. SURGEON HAD CALLED FOR X-RAYS PRIOR TO MY ARRIVAL, BUT BECAUSE THE VALVE DOES NOT HAVE ANY ORIENTATION MARKERS, WE WERE NOT ABLE TO VERIFY WHERE THE VALVE WAS SET BASED ON THE X-RAYS THAT HAD BEEN TAKEN. ONCE WE WERE ABLE TO VERIFY THAT THE X-RAY HAD BEEN TAKEN PROPERLY, WE WERE ABLE TO VERIFY THE VALVE SETTING. THE PATIENT WAS DOING WELL THROUGHOUT THE PROCESS, AS SURGEON STATES IN HIS EMAIL BELOW. THESE EVENTS HAPPENED OVER THE COURSE OF FOUR DAYS, (B)(6) 2011-(B)(6) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 568808 | CERTAS INLIN VLV ONLY W/SPHNGD | SHUNT, CENTRAL NERVOUS SYSTEM & COMPS | JXG | CODMAN & SHURTLEFF, INC MEDOS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |