MAUDE Adverse Event Report: AESCULAP, INC. PROGAV; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	FV431T
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Patient received a ventriculoperitoneal shunt last year.He came back to the hospital with ams and ct scan showed larger ventricles.We tapped the shunt with no infection.Wanted to change the valve setting of the programmable progav valve to a lower setting to improve the drainage, however, we could not change the setting.Patient needed to be taken to the or to change the valve.

• Brand Name: PROGAV
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): AESCULAP, INC.; 3773 corporate pkwy; center valley PA 18034
• MDR Report Key: 7629460
• Report Number: 7629460
• Device Sequence Number: 16753135
• Product Code: JXG
• UDI-Device Identifier: 04041906132439
• UDI-Public: (01)04041906132439
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2018
• Report Date (Section F): 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: FV431T
• Device Catalogue Number: FV431T
• Device Lot Number: 20032043
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/05/2018